Director, Global Product Quality - Manufacturing

Director, Global Product Quality – Manufacturing

The Director, Global Product Quality – Manufacturing leads the quality oversight of clinical and commercial products at CDMOs 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 has global responsibility for clinical and commercial product quality to ensure stable 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 clinical studies and commercial operations as well as drive continuous improvement.

Key Job Responsibilities:

• Responsible for overall Quality and compliance of GMP suppliers providing contract manufacturing, clinical packaging and labeling, distribution, and testing services for Otsuka Small Molecule and Biologics products
• Establishes and maintains the effectiveness of Quality Systems for managing the batch record review and disposition processes supporting Commercial Product (API, drug product, and final finished product)
• Works to maintain the effectiveness of Quality Management Systems for GMP activities supporting Investigational Medicinal Products and Commercial Product
• Leads resolution of product quality issues by driving robust root cause investigations and CAPA implementation and escalates quality issues to senior management when appropriate
• Oversees development and maintenance of Standard Operating Procedures, work instructions, forms, templates, and other documents associated with the systems noted above
• Ensures Quality Agreements are executed with Suppliers and that the agreements remain in compliance with local and global procedures
• Represents global product quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP
• Collaborates with project teams supporting key Otsuka projects to assure that goals set by the team as they relate to potential suppliers are consistent with local and global quality objectives and relevant governmental requirements
• Serves as Global Quality Product Champion and is responsible for monitoring and escalation of any situation with potential negative impact on clinical study supplies and/or supply chain for commercial product or impact to patients

Knowledge, Skills, Competencies, Education, and Experience Required:

• Bachelor's degree in Biology, Chemistry, or related field
• Minimum 12 years of combined experience in QA role and/or pharmaceutical manufacturing role, supporting GMP activities for Investigational Medicinal Products or Commercial Products
• Thorough understanding of the Drug Development process and cGMP regulatory requirements
• Ability to handle interactions and resolve issues with internal customers and GMP Suppliers in a tactful, professional and effective manner
• Experience with Small Molecule API and Drug Product manufacturing
• Strong analytical problem solving and decision-making skills
• Risk Management experience
• Position requires approximately 30% domestic travel; Occasional international travel may also be necessary

Preferred:

• Advance degree in Biology, Chemistry, or related field
• Experience with medical devices/combination products
• At least 8 years of Quality Management experience
• Experience with Biologics manufacturing

Competencies:

• Accountability for Results
• Strategic Thinking & Problem Solving
• Patient & Customer Centricity
• Impactful Communication
• Respectful Collaboration
• Empowered Development

Salary Range: Minimum $169,222.00 - Maximum $253,000.00, 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.