Manager, Quality Assurance, Logistics

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) ensures full integration of development and commercialization activities, from initiation of the clinical program for a compound through product positioning and global life cycle management, which will lead to globally consistent branding of our products.

 

Otsuka is seeking a Manager, Quality Assurance, Logistics who will carry out routine requirements of Quality Agreements (API, Drug Product, and Testing Laboratories) in accordance with cGMP, JGMP and EU-GMP.The individual will coordinate external audits and participate in resolution of problems related to our partners. In addition the individual will also prepare SOPs as they relate to Quality Assurance activities.

 

The specific duties assigned to the Manager, Quality Assurance, Logistics include:Oversee the quality control function and quality systems for Oncology Products including document control, validation/change control, internal/external audits, complaint handling, corrective and preventative actions.Responsible for product release - commercial and investigational materials.Responsible for the implementation of the Quality Systems for the Manufacturing Department and updates to the Manufacturing Guide.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.Assist in the development of departmental Standard Operating Procedures, Quality Systems Regulation (QSR) manual, etc.Responsible for assuring that our partners and OPDC meet their contractually agreed to quality commitments.  Contract development will be a task that arises from time to time.Participate 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.Work collaboratively with OAPI and OPC, as well as other CROs, to facilitate processing of materials to partners and adhere to timelines.

The successful candidate must meet the following minimum requirements:BS in Chemistry, Chemical Engineering, Physical Sciences or Medical Technology10 or more years experience in Pharmaceuticals with experience in Quality assurance/manufacturing. CPIM certification a plus.Proficient in the use of computers and computer software, including Microsoft Word, Excel, PowerPoint and Project.Excellent written and oral communication skills.Ability to operate in a multi-cultural, multifaceted corporate environment;Desire and enthusiasm to take on new challenges whether or not they are in job description;Task and Detail oriented.Must also be willing to travel approximately 20% of the time.

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 OPDC, Careers, then Employment Opportunities.  Enter 08-037 for keyword search. 

 

Otsuka is an Equal Opportunity Employer.