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Principal Product Quality Leader

Thousand Oaks, CA

Top 3 Must Have Skill Sets:    

• B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
• 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience with regulatory filings - specifications, process control
Analytical background is a great plus



Description:

Remote until COVID policy lifted
B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
• 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience with regulatory filings - specifications, process control
Analytical background is a great plus


Primary Responsibilities include the following:
• Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
• Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
• Conduct science and risk-based evaluation of complex process and product quality data
• Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
• Extract and analyze data from various sources and Quality systems
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations 

"This posting is for Contingent Worker, not an FTE"

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