Job Description

Job Summary

The Associate Director, Global Product Quality - Biologics  is responsible for directing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. 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.

Job Description

• Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products.
• Develops comprehensive quality strategies for complex biologic development programs that address unique manufacturing challenges.
• 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).
• Transforms biologic manufacturing quality challenges through innovative approaches that maintain product integrity while optimizing operational efficiency.
• Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance.
• Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests.
• 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 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.
• Serves as a Global Quality Product Champion with a focus on ensuring the quality of our biologics products, monitoring, and escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial products, or patient safety.

Qualifications

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 product and development project activities.
• 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.
• Proven experience with biologics GMP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.
• 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 and BLAs.
• Experience in driving continuous improvement projects.
• TrackWise Experience.
• Excellent interpersonal and communication skills.
• Position requires approximately 20% domestic travel; Occasional international travel may also be expected.

Preferred

• Advanced degree in Biology or other Physical Sciences.
• Experience with quality oversight of controlled substances.

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