Director, Product Quality Leader – PQL

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BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. is a leading global biotechnology company dedicated to transforming genetic discoveries into innovative medicines. Founded in 1997, the company has developed eight marketed products that address life-threatening genetic and lysosomal storage disorders such as achondroplasia and severe hemophilia A. BioMarin is also heavily invested in research and development, with a robust pipeline of investigational medicines at various clinical trial stages. The company's mission revolves around improving patient care by leveraging scientific expertise to understand the underlying causes of these conditions. BioMarin is committed to inclusivity and patient advocacy, engaging closely with communities to enhance care and quality of life for those with rare conditions.

📋 Description

• 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

🎯 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