Director, Product Quality Leader

🔥 5 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

Healthcare • 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 through post-commercialization • Make technical quality-related decisions and serve as the CMC team’s single point of contact for quality functions, risks and issues • Provide quality leadership for CMC-related strategic activities and drive quality decisions • Participate in CMC team meetings and technical forums, providing expertise for global strategies and implementation plans across the product lifecycle • Partner with CMC and Quality teams to identify, develop and prioritize long-term product strategies and initiatives • Create product-specific Quality strategies • Lead the cross-functional Quality Partner Team and manage deliverables aligned with CMC execution plans • Communicate relevant information between the Quality Partner Team, CMC Team and functional managers • Own and manage the product quality risk register, including issue identification, resolution, mitigation and escalation • Develop phase-appropriate product specifications and collaborate on the Quality Target Product Profile and product control strategy • Develop product comparability protocols and assessments for clinical-stage and commercial products • Interpret and apply regulatory guidelines and directives including 21 CFR, USP, EP, JP and ICH • Review and author regulatory submission sections • Review and approve Annual Product Reviews for commercial programs • Oversee and monitor CMC-related Health Authority commitments • Support or lead initiatives to improve PQL operational efficiency and effectiveness • Lead cross-portfolio initiatives to reduce technical quality risks

🎯 Requirements

• BA/BS in life sciences or related field required • Advanced degree desirable • 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 • Experience in both clinical and commercial phases of product lifecycle is highly desirable • Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus • Excellent interpersonal and communications skills • Ability to interface with a broad range of internal and external stakeholders at all levels of the organization • Demonstrated strong leadership capability with ability to align on, make and act on decisions while balancing speed, quality, and risk • Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment • Experience developing relationships focused on best-practice sharing and collaborative problem solving • Ability to work with ambiguity and complexity and continuously modify options and solutions across all levels of the organization • Results oriented; effectively manages multiple projects efficiently • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization • Effective public speaker • In-depth understanding and application of cGMP principles, concepts, practices and standards • Understanding of the international regulatory landscape preferred • Broad knowledge and experience in Quality with biologic and chemical processes, drug development, and analytical methods • Prior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory • Periodic travel is required

🏖️ Benefits

• Equal Opportunity Employer/Veterans/Disabled • An Equal Opportunity Employer • Periodic travel is required