Product Quality Leader
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Product Quality Leader (PQL) is accountable for quality strategies supporting the lifecycle management plan for clinical and commercial products. The PQL is a core member of the CMC team and the single Quality point of contact for the product.
The PQL leads a Quality Partner Team (QPT) to develop and execute quality deliverables supporting CMC strategies, including identification and escalation of risks. Additionally, the PQL and QPT are responsible to deliver a clear strategy to maintain and improve product quality in alignment with business drivers.
This position requires a broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods and understanding of the international regulatory landscape.
- Attend and participate fully in CMC team meetings, and other relevant technical forums, to provide technical quality expertise to influence global strategies and ensure robust implementation plans for product/program changes
- Partner with CMC team and quality organization to identify, develop and prioritize Quality initiatives for product
- Lead the Quality Partner Team(s) to define, monitor and identify actions to drive product quality health metrics and manage quality deliverables for CMC
- Own and manage product quality risk register to ensure identification and escalation of product quality risks to CMC team and/or Senior Management and prioritization of corresponding actions
- Support product transition from clinical to commercial, new product introductions and tech transfers
- Review Annual Product Review (APR)
- Provide technical quality input for briefing books in preparation for health authority (HA) scientific advice gathering meetings and attend meetings as warranted
- Provide technical quality and/or strategic support to sites during product pre-approval inspections, and routine GMP inspections as requested by site
- Review and author regulatory submissions and provide input to ensure clarity and consistency of messaging across Quality owned sections
- Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
- Translate complex scientific or quality concepts and communicate, as appropriate, across the organization
- Influence decision makers and utilizes sound problem-solving skills to recommend options and implement effective solutions.
- Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
- Demonstrated ability for highly developed ability to communicate in both oral and written domains.
- Provide oversight and monitor CMC related submission related commitments and ensure timely completion. Provide routine updates and visibility of submission commitments to functional and senior management
- Identify and lead cross portfolio initiatives or improvements that will reduce overall risks as required
- 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
- 5+ years of prior management level experience
- Excellent interpersonal and communications skill
- Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally
- Ability to work effectively with stakeholders and QPT members in various countries/regions
- Demonstrated ability to partner with other functional groups to achieve business objectives
- 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
- Builds strong, effective working teams; builds relationships to share best practices, and collaboratively solve problems
- In-depth understanding and application of cGMP principles, concepts, practices and standards
- Prior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development/manufacturing sciences and Quality/Regulatory
- Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods and understanding of the international regulatory landscape preferred
- BA/BS in life sciences or related field
- Advanced degree desirable, but not required
- Other continuing education initiatives or relevant industry or compliance certifications
Ability to travel up to 30% as required
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.