Otsuka Pharmaceutical Company
We are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being.
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A Day In The Life Of

Our People

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"Otsuka-people dare to dream and we take the road less traveled to influence the future."

Kevin Donovan

SVP, OTSUKA-PEOPLE, BUSINESS SERVICES & COMMUNICATIONS

Are you an Otsuka-Person?

If your answer is yes, and you are looking for a career in an exciting and innovative company...

 

Career Opportunities

Director Global Product Quality
Position Summary:The Director, Global Product Quality provides guidance and expertise to OAPI/OPDC in the interpretation and implementation of manufacturing and quality system regulations applicable to commercial drug products, medical devices and combination products. Ensures that SOPs describing internal processes are developed and maintained and that the appropriate quality audits are conducted and responded to in order to maintain compliance with GMP regulations and guidelines.Host FDA for on-site GxP inspectionsProvide global expertise for data integrity across GxP functionsDesigns and implements institutional quality management systems and quality programs to ensure sustained GMP/QSR compliance.Compliance with QSR 820 and Part 4Compliance with 210 and 211Otsuka Policies and ProceduresManages the oversight of vendors and contractors, including qualification and contract management.Deals with disposition (release/rejection) of components, as well as investigational and commercial finished medical device and drug products.Manages the batch record review and release process Quality Management Activities of Commercial Product (API, drug product, and final finished product). Review the Batch records for API, Bulk, Commercial finished products (drug products or medical devices) and release the product for further processing or commercial distribution as applicable.Coordinate and work with Suppliers, Digital Medicine, Technical Operations, and Medical Device Division and regulatory Affairs to establish Design Controls (Design History file and Device Master Record, etc.) and oversee Risk Management Activities for Medical Devices, Combination Products and software applications (Mobile Apps, Web Applications etc.).Collaborate with Technical Operations, Medical Device Division and Regulatory Affairs for any changes/development to Design/Design History File/Device Master record for medical devices and/or combination products and software applications (Mobile Apps, Web Applications etc.).Ensures Quality Agreements are executed with third-party vendors; oversee compliance with Quality Agreements.Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines.Quality Collaboration with CMOs for the review of process changes and improvements, investigations and root cause analysis of process deviations, corrections, corrective actions, out of trends, and OOS as applicable.Provide oversight and ensure that Change controls, deviations/investigations, CAPAs are initiated and executed as applicable in a timely manner. Liaises with Senior Director, Auditing and Monitoring, to plan and manage the conduct of periodic internal audits to assure that departments are meeting regulatory requirements and complying with quality management system requirements.Liaises with Senior Director, Auditing and Monitoring to ensure the timely execution of audit plans to assess and maintain compliance with global manufacturing and quality system regulations for pharmaceuticals and medical devices.Manages and Host GMP Inspections and assures the preparation for, management of and response to regulatory inspections as applicable in collaboration with OAPI.Provides leadership in the coordination and management of any corrections, removals or recalls or field alerts with other quality related crisis.Presents to Senior Director/Senior Management, GMP/QSR performance metrics update, trend overview, and other strategic analyses related to GMPs and QSRsEnsures all required GMP/QSR training requirements are satisfied for the department.Proactively manages a staff FTEs and independent contractors to ensure the department is operating effectively, efficiently, and within budget.Conduct internal audits and supplier audits to ensure compliance with Otsuka requirements as well as applicable regulatory requirementsQualifications:Bachelor's degree in Engineering or other Physical Sciences or + 10 years of combined and/or pharmaceutical/Medical devices manufacturing, QA or QC assurance roles6-8 years of Quality Management experience in the medical device and/or pharmaceutical manufacturingExpertise in FDA 21 CFR Parts 820, 211 and 210 quality system requirementsExpertise in Data Integrity requirementsAbility to manage and prioritize multiple tasksExperience in using MS Word, Excel, and AccessExcellent interpersonal and communication skillsPreferred:Lead Auditor/Internal Auditor Certificate for ISO 13485 quality management systemExperience with TrackWise System for handling deviations, change controls, complaints, investigations Disclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud ScamsJob postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career websitehttps://external-otsuka.icims.com/. Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
Director Global Product Quality
Position Summary:The Director, Global Product Quality provides guidance and expertise to OAPI/OPDC in the interpretation and implementation of manufacturing and quality system regulations applicable to commercial drug products, medical devices and combination products. Ensures that SOPs describing internal processes are developed and maintained and that the appropriate quality audits are conducted and responded to in order to maintain compliance with GMP regulations and guidelines.Host FDA for on-site GxP inspectionsProvide global expertise for data integrity across GxP functionsDesigns and implements institutional quality management systems and quality programs to ensure sustained GMP/QSR compliance.Compliance with QSR 820 and Part 4Compliance with 210 and 211Otsuka Policies and ProceduresManages the oversight of vendors and contractors, including qualification and contract management.Deals with disposition (release/rejection) of components, as well as investigational and commercial finished medical device and drug products.Manages the batch record review and release process Quality Management Activities of Commercial Product (API, drug product, and final finished product). Review the Batch records for API, Bulk, Commercial finished products (drug products or medical devices) and release the product for further processing or commercial distribution as applicable.Coordinate and work with Suppliers, Digital Medicine, Technical Operations, and Medical Device Division and regulatory Affairs to establish Design Controls (Design History file and Device Master Record, etc.) and oversee Risk Management Activities for Medical Devices, Combination Products and software applications (Mobile Apps, Web Applications etc.).Collaborate with Technical Operations, Medical Device Division and Regulatory Affairs for any changes/development to Design/Design History File/Device Master record for medical devices and/or combination products and software applications (Mobile Apps, Web Applications etc.).Ensures Quality Agreements are executed with third-party vendors; oversee compliance with Quality Agreements.Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines.Quality Collaboration with CMOs for the review of process changes and improvements, investigations and root cause analysis of process deviations, corrections, corrective actions, out of trends, and OOS as applicable.Provide oversight and ensure that Change controls, deviations/investigations, CAPAs are initiated and executed as applicable in a timely manner. Liaises with Senior Director, Auditing and Monitoring, to plan and manage the conduct of periodic internal audits to assure that departments are meeting regulatory requirements and complying with quality management system requirements.Liaises with Senior Director, Auditing and Monitoring to ensure the timely execution of audit plans to assess and maintain compliance with global manufacturing and quality system regulations for pharmaceuticals and medical devices.Manages and Host GMP Inspections and assures the preparation for, management of and response to regulatory inspections as applicable in collaboration with OAPI.Provides leadership in the coordination and management of any corrections, removals or recalls or field alerts with other quality related crisis.Presents to Senior Director/Senior Management, GMP/QSR performance metrics update, trend overview, and other strategic analyses related to GMPs and QSRsEnsures all required GMP/QSR training requirements are satisfied for the department.Proactively manages a staff FTEs and independent contractors to ensure the department is operating effectively, efficiently, and within budget.Conduct internal audits and supplier audits to ensure compliance with Otsuka requirements as well as applicable regulatory requirementsQualifications:Bachelor's degree in Engineering or other Physical Sciences or + 10 years of combined and/or pharmaceutical/Medical devices manufacturing, QA or QC assurance roles6-8 years of Quality Management experience in the medical device and/or pharmaceutical manufacturingExpertise in FDA 21 CFR Parts 820, 211 and 210 quality system requirementsExpertise in Data Integrity requirementsAbility to manage and prioritize multiple tasksExperience in using MS Word, Excel, and AccessExcellent interpersonal and communication skillsPreferred:Lead Auditor/Internal Auditor Certificate for ISO 13485 quality management systemExperience with TrackWise System for handling deviations, change controls, complaints, investigations Disclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud ScamsJob postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career websitehttps://external-otsuka.icims.com/. Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
Neuroscience Account Manager- Miami
We are committed to mental health and looking for Account Managers who share our passion to support the promotion and co-promotion of neuroscience products. Over the years, our innovations in schizophrenia and major depressive disorder (MDD) have advanced, and our knowledge of other mental health illnesses and disorders continues to grow.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:Think differently by challenging conventional thinking - Are intellectually curious and life-long learnersAre effective, 'get it done' and have a sense of ownershipAre comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connectAre remarkable in their chosen field KeyJob Expectations/Responsibilities:Can be counted on to exceed goals successfully, very bottom-line oriented, steadfastly pushes self and others for resultsCan quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaborationSummarizes complex situations or data sets into easily understood informationMakes decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decision makingContinually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactEvaluates the results of timelines and resource plans and recommends changesCoordinates with alliance company sales management team within region geographyManages key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomesAbility to sell a portfolio of productsCompliance Management:Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulationsComplies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activitiesKnowledge, Skills, Competencies, Education, and Experience:Required:2 years of pharmaceutical sales experience and/OR 3-5 years of business to business outside sales experienceMinimum of 1 year ranked in top 25% with overall salesAble to provide last 2 years of performance review documentationWilling to un-learn entrenched ways of doing thingsAbility to learn new and complex materials and conceptsDemonstration of customer focus or patient centricityThinks strategically; intuitively makes connections and associationsCommunicates effectively; strong and engaging facilitatorDemonstrates managerial courage and strong professional presenceHumility - Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four year college or university (or the equivalent if education obtained outside of the United States) - Valid Driver's license and a good driving record under Otsuka policyPreferred:- Active leadership experiences*Up to 20% travel (trips to District, Regional and National Meetings) Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-and-talent/our-employee-value-package.htmlDisclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud ScamsJob postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career websitehttps://external-otsuka.icims.com/. Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
Neuroscience Account Manager- Miami
We are committed to mental health and looking for Account Managers who share our passion to support the promotion and co-promotion of neuroscience products. Over the years, our innovations in schizophrenia and major depressive disorder (MDD) have advanced, and our knowledge of other mental health illnesses and disorders continues to grow.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:Think differently by challenging conventional thinking - Are intellectually curious and life-long learnersAre effective, 'get it done' and have a sense of ownershipAre comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connectAre remarkable in their chosen field KeyJob Expectations/Responsibilities:Can be counted on to exceed goals successfully, very bottom-line oriented, steadfastly pushes self and others for resultsCan quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaborationSummarizes complex situations or data sets into easily understood informationMakes decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decision makingContinually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactEvaluates the results of timelines and resource plans and recommends changesCoordinates with alliance company sales management team within region geographyManages key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomesAbility to sell a portfolio of productsCompliance Management:Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulationsComplies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activitiesKnowledge, Skills, Competencies, Education, and Experience:Required:2 years of pharmaceutical sales experience and/OR 3-5 years of business to business outside sales experienceMinimum of 1 year ranked in top 25% with overall salesAble to provide last 2 years of performance review documentationWilling to un-learn entrenched ways of doing thingsAbility to learn new and complex materials and conceptsDemonstration of customer focus or patient centricityThinks strategically; intuitively makes connections and associationsCommunicates effectively; strong and engaging facilitatorDemonstrates managerial courage and strong professional presenceHumility - Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four year college or university (or the equivalent if education obtained outside of the United States) - Valid Driver's license and a good driving record under Otsuka policyPreferred:- Active leadership experiences*Up to 20% travel (trips to District, Regional and National Meetings) Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-and-talent/our-employee-value-package.htmlDisclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud ScamsJob postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career websitehttps://external-otsuka.icims.com/. Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
Neuroscience Account Manager (Injectable)- Oklahoma City
We are committed to mental health and looking for Account Managers who share our passion to support the promotion and co-promotion of neuroscience products. Over the years, our innovations in schizophrenia and major depressive disorder (MDD) have advanced, and our knowledge of other mental health illnesses and disorders continues to grow.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:Think differently by challenging conventional thinking - Are intellectually curious and life-long learnersAre effective, 'get it done' and have a sense of ownershipAre comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connectAre remarkable in their chosen field KeyJob Expectations/Responsibilities:Can be counted on to exceed goals successfully, very bottom-line oriented, steadfastly pushes self and others for resultsCan quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaborationSummarizes complex situations or data sets into easily understood informationMakes decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decision makingContinually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactEvaluates the results of timelines and resource plans and recommends changesCoordinates with alliance company sales management team within region geographyManages key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomesAbility to sell a portfolio of productsCompliance Management:Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulationsComplies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activitiesKnowledge, Skills, Competencies, Education, and Experience:Required:2 years of pharmaceutical sales experience and/OR 3-5 years of business to business outside sales experienceMinimum of 1 year ranked in top 25% with overall salesAble to provide last 2 years of performance review documentationWilling to un-learn entrenched ways of doing thingsAbility to learn new and complex materials and conceptsDemonstration of customer focus or patient centricityThinks strategically; intuitively makes connections and associationsCommunicates effectively; strong and engaging facilitatorDemonstrates managerial courage and strong professional presenceHumility - Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four year college or university (or the equivalent if education obtained outside of the United States) - Valid Driver's license and a good driving record under Otsuka policyPreferred:- Active leadership experiences*Up to 20% travel (trips to District, Regional and National Meetings) Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-and-talent/our-employee-value-package.htmlDisclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud ScamsJob postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career websitehttps://external-otsuka.icims.com/. Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
Neuroscience Account Manager (Injectable)- Oklahoma City
We are committed to mental health and looking for Account Managers who share our passion to support the promotion and co-promotion of neuroscience products. Over the years, our innovations in schizophrenia and major depressive disorder (MDD) have advanced, and our knowledge of other mental health illnesses and disorders continues to grow.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:Think differently by challenging conventional thinking - Are intellectually curious and life-long learnersAre effective, 'get it done' and have a sense of ownershipAre comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connectAre remarkable in their chosen field KeyJob Expectations/Responsibilities:Can be counted on to exceed goals successfully, very bottom-line oriented, steadfastly pushes self and others for resultsCan quickly find common ground and solve problems for the good of all, can represent his/her own interests and yet be fair to others, can solve problems with peers, direct reports and matrix team members with a minimum of noise, is seen as a team player and is cooperative, easily gains trust and support of colleagues, encourages collaborationSummarizes complex situations or data sets into easily understood informationMakes decisions using information gathered and develops others in their ability to organize their thoughts, identify patterns in data, and facilitate decision makingContinually analyzes performance against plan and is proactive in planning sales activities to maximize customer calls and impactEvaluates the results of timelines and resource plans and recommends changesCoordinates with alliance company sales management team within region geographyManages key account coordination along with the District Managers to develop relationships leading to increased profitability and better patient outcomesAbility to sell a portfolio of productsCompliance Management:Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulationsComplies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activitiesKnowledge, Skills, Competencies, Education, and Experience:Required:2 years of pharmaceutical sales experience and/OR 3-5 years of business to business outside sales experienceMinimum of 1 year ranked in top 25% with overall salesAble to provide last 2 years of performance review documentationWilling to un-learn entrenched ways of doing thingsAbility to learn new and complex materials and conceptsDemonstration of customer focus or patient centricityThinks strategically; intuitively makes connections and associationsCommunicates effectively; strong and engaging facilitatorDemonstrates managerial courage and strong professional presenceHumility - Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four year college or university (or the equivalent if education obtained outside of the United States) - Valid Driver's license and a good driving record under Otsuka policyPreferred:- Active leadership experiences*Up to 20% travel (trips to District, Regional and National Meetings) Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-and-talent/our-employee-value-package.htmlDisclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Statement Regarding Job Recruiting Fraud ScamsJob postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career websitehttps://external-otsuka.icims.com/. Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.
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