Associate Director, Global Product Quality - GMP Processes

Job Summary

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 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

Required

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field (Master’s or PhD preferred).
• 8+ years of experience in pharmaceutical quality, regulatory affairs, or technical operations.
• Proven expertise in managing and optimizing PQC, CAPA, deviation, and change control systems.
• Experience leading cross-functional teams and global projects.
   
• Skills & Competencies:
• Strong knowledge of GMP, ICH guidelines, and global regulatory requirements.
• Strong analytical skills with experience in quality metrics, risk management, and root cause analysis.
• Excellent project management, communication, and stakeholder engagement skills.
• Strategic thinker with a continuous improvement mindset.
• Proficiency in quality systems and digital tools (e.g., TrackWise, Veeva).

Preferred Experience:

• Certification in Lean, Six Sigma, or Quality Auditing.
• Experience in global matrix organizations and cross-cultural collaboration.
• Knowledge of digital transformation in quality processes

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

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.

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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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