We transform lives through genetic discovery.
Director, Product Quality Leader – PQL
Location
United States
Posted
1 day ago
Salary
0
Seniority
Senior
Job Description
Director, Product Quality Leader – PQL
BioMarin Pharmaceutical Inc.
• Serve as a technical quality expert for one or more products during clinical development • Make technical quality-related decisions and serve as the single point of contact on the CMC team for all quality functions • Participate in CMC team meetings, providing technical quality expertise • Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives • Lead the cross-functional Quality Partner Team supporting Quality-related CMC deliverables • Own and manage the product quality risk register to ensure identification, resolution, mitigation and/or escalation of product quality issues • Develop a phase appropriate product specification as part of product control strategy creation • Interpret and apply applicable regulatory guidelines and directives to product quality • Provide oversight and monitor CMC related Health Authority commitments • Identify and lead cross portfolio initiatives or improvements
Job Requirements
- BA/BS in life sciences or related field required
- 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry; preferred experience in biologics product development and licensure or technical support
- Excellent interpersonal and communications skills
- Experience supporting combination products across clinical and commercial stages
- In-depth understanding and application of cGMP principles, concepts, practices and standards
- Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods
- Prior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory.
Benefits
- Health insurance
- Retirement plans
- Paid time off
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