Principal Product Quality Leader – Biopharma (JP8393)
Thousand Oaks, CA. (Remote until COVID restrictions are lifted)
Corporate Product Quality
12 months with likely extension
3 Key Consulting is hiring a Principal Product Quality Leader
for a consulting engagement with our client, a leading global biopharmaceutical company.
Primary Responsibilities include the following:
- 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
Employee Value Proposition:
- 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
Opportunity for growth and being able to work with a dynamic team. Exposure to a large company and will gain more experience.
No jumpy work history
|Phone interviews and panel
We invite qualified candidates to send your resume to email@example.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.