Associate Director, Global Product Quality - Biologics

Associate Director, Global Product Quality - Biologics

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.

Responsibilities include :

• Directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products.
• Developing comprehensive quality strategies for complex biologic development programs that address unique manufacturing challenges.
• Establishing and maintaining the effectiveness of quality systems for managing the batch record review and release process.
• Transforming biologic manufacturing quality challenges through innovative approaches.
• Working collaboratively within the Global Quality Dept. and other functions to assure compliance.
• Managing reports and trends to the Management Representative.
• Establishing and maintaining standard operating procedures, work instructions, forms, templates.
• Improving supplier quality performance for batch record review and release.
• Interfaces with Contract Manufacturers / Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive quality improvements.
• Representing global quality during execution of product technical transfer activities.
• Assisting in conducting audits of Contract Manufacturers / Laboratories.
• Responsible for reviewing, drafting, and augmenting existing quality agreements with external service providers.
• Serving as a global quality product champion.

Qualifications :

Competencies :

Salary : Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity.

Company benefits :

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com).

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