Associate Director, Global Product Quality-Controlled Substances

Job Summary

The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of clinical and commercial controlled substances manufactured at CMOs under contract by Otsuka. This role is responsible to ensure that clinical and commercial products that may be classified as controlled substances are manufactured, packed, labelled, stored, and transported accordance with regulatory expectations and applicable cGMP/GDP quality standards.

This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka’s patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement.

• Responsible for directing quality oversight of GMP contract manufacturers of controlled substances for Otsuka clinical and commercial products

• Support cross-functional teams to ensure alignment and compliance with controlled substance regulations.

• Provides guidance and expertise to sites and business units to assess the facilities, and/or business operations, compliance of DEA regulations and site procedures.

• Managing, updating and improvements of corporate controlled substance oversight standards. Provide oversight to ensure inspections readiness.

• Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product) for controlled substances

• Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance

• Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above
  
  Improves supplier quality performance for batch record review and release process for

• OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products.

• Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc.

• Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP

• Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable controlled substance regulatory requirements

• Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met

Required

• Bachelor’s degree in Chemistry, Biology or other Physical Sciences

• Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial and development controlled substances.

• Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects.

• Expertise in conducting root cause investigations and driving CAPA implementation

• Ability to supervise multiple direct reports and projects in a fast-paced environment

• Demonstrated success in working on and leading cross functional teams

• Experience with Pre Approval Inspections for NDAs

• Experience in driving continuous improvement projects

• Track Wise Experience

• Excellent interpersonal and communication skills

• Position requires approximately 20% domestic travel;
  Occasional international travel may also be expected.

Preferred

• Advanced degree in Chemistry or other Physical Sciences

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.

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