Associate Director, Global Product Quality

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. 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, and other documents. Improving supplier quality performance for batch record review and release process. 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 with a focus on ensuring the quality of our biologics products. Qualifications required include: 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. 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 qualifications include: Advanced degree in Biology or other Physical Sciences. Experience with quality oversight of controlled substances. Competencies: Accountability for Results Strategic Thinking & Problem Solving Patient & Customer Centricity Impactful Communication Respectful Collaboration Empowered Development Salary: Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity. Company benefits include 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). Statement Regarding Job Recruiting Fraud Scams: Otsuka will never ask for any financial information or for payment of money during the job application process. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. 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