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Principal Product Quality Leader – Biopharma - open for remote (JP8393)

Thousand Oaks, Ca · Biotech/Pharmaceutical
Job Title:  Principal Product Quality Leader – Biopharma (JP8393)
Location: Thousand Oaks, CA. (Remote until COVID restrictions are lifted)
Employment Type:  Contract
Business Unit: Corporate Product Quality
Duration: 12 months with likely extension
Posting Date: 03/19/2021
3 Key Consulting is hiring a Principal Product Quality Leader for a consulting engagement with our client, a leading global biopharmaceutical company.
Job Description:
  • 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
  • 5-10 years experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
  • 5-10 years experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformance
  • 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

 Employee Value Proposition:
Opportunity for growth and being able to work with a dynamic team. Exposure to a large company and will gain more experience.
Red Flags:
No jumpy work history
Interview process:
Phone interviews and panel
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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