[Hiring] Director, Global Product Quality - Manufacturing @Otsuka Pharmaceutical Co., Ltd.

Role Description

The Director, Global Product Quality – Manufacturing Product Quality 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.

Qualifications

• 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

Requirements

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

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
• Other company provided benefits