BioMarin Pharmaceutical Inc.

We transform lives through genetic discovery.

Director, Product Quality Leader

DirectorDirectorFull TimeRemoteTeam 1,001-5,000Since 1997H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

86 days ago

Salary

Not specified

Bachelor Degree12 yrs expEnglish

Job 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 • Provide efficient and effective quality leadership of CMC-related strategic activities • Participate fully in CMC team meetings, providing technical quality expertise • Lead the cross-functional Quality Partner Team supporting Quality-related CMC deliverables • Collaborate with CMC Team and the Quality organization to identify and develop long-term product strategies • Own and manage the product quality risk register • Responsible for developing product comparability protocols and assessments

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
  • Experience in both clinical and commercial phases of product lifecycle is highly desirable.
  • Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
  • In-depth understanding and application of cGMP principles, concepts, practices and standards
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization
  • Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods.

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off

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