Associate Director, Global Product Quality - GMP Processes

Associate Director, Global Product Quality Gmp Process

The Associate Director, Global Product Quality GMP Process is responsible for enabling the optimization and harmonization of key GMP quality practices across the global organization. This role defines, maintains, and continuously improves critical quality system elements including Product Quality Complaints (PQC), Corrective and Preventive Actions (CAPA), Deviations, and Change Control, ensuring compliance with global regulatory requirements and internal standards. The successful candidate will lead cross-functional initiatives to enhance quality performance, reduce risk, and foster a culture of continuous improvement.

Key Responsibilities :

• Process Ownership & Governance : Lead the global strategy and governance for Product Quality Complaints, CAPA, Deviations, and Change Control processes. Develop and implement global standards, procedures, and best practices to ensure consistency and compliance across all global affiliates. Partner with regional and site quality leaders to drive process improvements, enhance efficiency, and ensure alignment with corporate quality objectives.
• Cross-functional Leadership : Collaborate with Regulatory Affairs, Technical Operations, Manufacturing, and Supply Chain to ensure alignment and integration of quality into product lifecycle activities.
• Quality Strategy Development : Lead or support global projects related to digital transformation, system upgrades, and process optimization.
• Inspection Readiness & Compliance : Support regulatory inspections and internal audits, ensuring readiness and robust documentation of quality system performance.
• Metrics and Reporting : Monitor and report on key performance indicators (KPIs) to senior leadership, identifying opportunities for improvement and risk mitigation.
• Training & Change Management : Provide leadership, coaching, and subject matter expertise to global teams on GMP compliance and quality system execution.

Qualifications :

Competencies :

Salary Range : Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity : The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline : This will be posted for a minimum of 5 business days.

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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