Senior Manager, Pharmaceutical/Medical Device Quality Management

Otsuka America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast-growing healthcare company that commercializes Otsuka-discovered and other product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and gastrointestinal therapeutic treatments.

 

Otsuka is seeking a Senior Manager, Pharmaceutical/Medical Device Quality Management with the ability to employ a variety of quality methodologies required to support international technical and regulatory requirements.  This person will have the opportunity to work with a highly skilled work force from around the world and support them in understanding US regulations and requirements. 

 

The specific duties assigned to the Senior Manager, Pharmaceutical/Medical Device Quality Management are as follows:Responsible for product release - commercial, device and investigational materials. Responsible for the maintenance of the Quality System.Interfaces with project teams to assure that the goals set by the team are consistent with relevant governmental requirements, including but not limited to the US. Maintains and oversees the development of departmental Standard Operating Procedures, Quality System Regulation (QSR) manual, etc. Responsible for assuring that our partners and OAPI meet their contractually agreed to quality commitments.  Contract development will be a task that arises from time to time. Participates in the selection of suitable third party contractors, including but not limited to Auditing potential and current suppliers to assure compliance with cGMP and other relevant regulations. Works in cooperation with all OAPI and OPDC, as well as other CROs, to facilitate processing of materials to the clinic and adhere to timelines.

 

The successful candidate must meet the following minimum requirements:BS in Chemistry, Chemical Engineering or Physical Sciences7-10 years experience in Pharmaceutical and/or Device manufacturing environment in the quality areasExperience in supervising a small staff and mentoring existing personnelProficient in managing professional individuals in a matrix environmentFully understands and comprehends the cGMP, including Part 11 and regulations pertaining to medical devices, Parts 812 and 814, etc.Willing to work with a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goalsWilling to travel domestically and internationally approximately 25% of their work schedule

 

We offer a competitive compensation and benefits package plus a positive work environment, which encourages personal growth and achievement.

 

For immediate consideration, qualified candidates should apply online at www.otsuka.com   Click on OAPI,  Careers, then Employment Opportunities.  Enter 07-035 for keyword search.  Applicants may also submit resumes via email to humanresources@otsuka.com .  Due to the volume of resumes, only applicants considered for interviews will be contacted. 

 

Otsuka is an Equal Opportunity Employer.