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Director, Product Quality Leader

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BioMarin Pharmaceutical

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Location:
United States

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

164000.00 - 225500.00 USD / Year
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Job Description:

This individual will serve as a technical quality expert for one or more products during clinical development all the way through post-commercialization. The role is responsible for making technical quality-related decisions and serving as the single point of contact on the CMC (Chemistry, Manufacturing and Controls) team for all quality functions, risks and issues associated with the assigned products. As a core member of the CMC team, the PQL provides efficient and effective quality leadership of CMC-related strategic activities and drives associated quality decisions.

Job Responsibility:

  • Serve as a technical quality expert for one or more products during clinical development through post-commercialization
  • Make technical quality-related decisions
  • Serve as the single point of contact on the CMC team for all quality functions, risks and issues
  • Provide efficient and effective quality leadership of CMC-related strategic activities
  • Drive associated quality decisions
  • Participate fully in CMC team meetings and other relevant technical forums
  • Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives
  • Accountable for creation of the product-specific Quality strategy
  • Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables
  • Own and manage the product quality risk register
  • Responsible for developing a phase appropriate product specification
  • Collaborate with CMC Lead to establish a phase appropriate Quality Target Product Profile (QTPP)
  • Responsible for developing product comparability protocols and assessments
  • Interpret and apply applicable regulatory guidelines and directives
  • Review and author regulatory submissions sections
  • Responsible for the review and approval of Annual Product Review for represented commercial programs
  • Provide oversight and monitor CMC related Health Authority commitments
  • Support, or lead, efforts to identify, define, and mobilize initiatives to improve the efficiency and effectiveness of PQL operational processes
  • Identify and lead cross portfolio initiatives or improvements

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
  • Demonstrated strong leadership capability
  • Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
  • Highly capable of building strong, effective working teams
  • Skilled in the ability to work with ambiguity and complexity
  • Results oriented
  • effectively manages multiple projects efficiently
  • Excellent written and verbal skills
  • In-depth understanding and application of cGMP principles, concepts, practices and standards
  • Understanding of the international regulatory landscape preferred
  • 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

Nice to have:

  • Experience supporting combination products across clinical and commercial stages, including device quality considerations
  • Understanding of the international regulatory landscape
What we offer:
  • Discretionary annual bonus
  • Discretionary stock-based long-term incentives
  • Paid time off
  • Company-sponsored medical, dental, vision, and life insurance plans

Additional Information:

Job Posted:
December 26, 2025

Employment Type:
Fulltime
Work Type:
Remote work
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