Global Product Quality Director, GMP & Supply Champion

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 169,222 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life Insurance

Disability Insurance

Tuition Reimbursement

Student Loan Assistance

401(k) Match

Flexible Time Off

Paid Holidays

Paid Leave

Job summary

Otsuka Pharmaceutical Companies (U.S.) seeks a Director, Global Product Quality – Manufacturing Product Quality to lead the quality oversight of clinical and commercial products sourced from GMP suppliers. The role ensures manufacturing, packing, labeling, storage, and transport comply with regulatory expectations and cGMP standards, with global responsibility to maintain stable patient supply.

The incumbent will drive Quality Systems, CAPA, and product transfers while collaborating with

Qualifications

• Bachelor's degree in Biology, Chemistry, or related field.
• Minimum 12 years of combined QA or pharmaceutical manufacturing experience.
• 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.

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

Skills

Quality Assurance

GMP Regulation

Root Cause Investigation

CAPA Management

Problem Solving

Travel 30%

Education

Bachelor’s degree in Biology, Chemistry, or related field

Advanced degree preferred

Job description

Otsuka Pharmaceutical Companies (U.S.) seeks a Director, Global Product Quality – Manufacturing Product Quality to lead the quality oversight of clinical and commercial products sourced from GMP suppliers. The role ensures manufacturing, packing, labeling, storage, and transport comply with regulatory expectations and cGMP standards, with global responsibility to maintain stable patient supply.

The incumbent will drive Quality Systems, CAPA, and product transfers while collaborating with