Executive Director – Cell Therapy Global Product Quality
| Company | Bristol Myers Squibb |
|---|---|
| Location | Seattle, WA, USA, Summit, NJ, USA, Devens, MA, USA |
| Salary | $260860 – $316096 |
| Type | Full-Time |
| Degrees | |
| Experience Level | Senior, Expert or higher |
Requirements
- Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required.
- Experience with review of commercial and clinical market applications, supplements or similar regulatory documentation is required.
- Demonstrated decision making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements are required.
- Demonstrated influential leadership expertise and experience with senior level interactions and influence with Technical, Development, Quality and Compliance, Supply Chain and Regulatory functions.
- Demonstrated people management experience.
Responsibilities
- Leads a team of Quality Product Leaders with responsibility for cell therapy products and clinical pipeline assets.
- Develops and ensures effective implementation of quality lifecycle strategies for cell therapy commercial, clinical and development products.
- Acts as lead Quality management reviewer/approver of regulatory submissions and responses to global agencies queries.
- Represents Global Product Quality at Cell Therapy Development and Operations forums and governance committees.
- Develops robust communication and tracking tools to enable efficient and effective decision-making and work processes.
Preferred Qualifications
- Experience in Cell Therapy (preferred), Biologics and Sterile manufacturing or technical support.