Director, Global Quality GMP Processes

The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for benchmarking, standardizing, and optimizing global quality processes across the organization. This role ensures that product quality systems are aligned with Good Manufacturing Practices (GMP) and regulatory requirements while driving efficiency, consistency, and continuous improvement across all regions and product lines.

The Director will lead global initiatives to harmonize and enhance processes related to product quality complaints, deviations, CAPA, and management reporting, ensuring timely and effective resolution and robust compliance.

Key Responsibilities

• Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for:
  • Product Quality Complaints
  • Corrective and Preventive Actions (CAPA)
  • Deviations
  • Management Reporting and Trending
     
• Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency.
• GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards.
• Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates.
• Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation.
• Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies.
• Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making.
• Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence.

Qualifications

Required

Required Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred.
• Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role.
• Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820).
• Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes.
• Strong analytical and problem-solving skills with a data-driven mindset.
• Excellent communication, leadership, and stakeholder management skills.
• Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools.
• Ability to travel internationally as needed.

Preferred

• Basic understanding of artificial intelligence and advanced analytics
• Experience supporting risk management programs or frameworks.
• Familiarity with quality management systems and digital tools.

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.

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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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.