Director, Product Quality Leader
BioMarin Pharmaceutical Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
product comparability protocolsquality risk managementcGMP principlesbiologics product developmentanalytical methodsclinical developmentcommercial phases of product lifecyclequality leadershipquality functionsquality-related CMC deliverables
Soft skills
communication skillsinfluencing stakeholdersdriving accountabilitydecision-makingcollaborationleadershipcross-functional teamworkstrategic thinkingproblem-solvingorganizational skills