Senior Director Quality Site Head
2 days ago
Pendulum is a pioneering company that is revolutionizing the field of microbiome research and development. Our mission is to improve human health and well-being by understanding and restoring the balance of the human microbiome.
Our team is dedicated to creating innovative solutions that address the complex relationships between the microbiome, human health, and the environment. We are committed to advancing the field of microbiome research and development through cutting-edge science, technology, and collaboration.
Job SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Quality team as the Quality Site Head. The successful candidate will be responsible for overseeing all Quality Unit functions, including QA, QC, and Quality Systems, and collaborating with internal business partners to deliver the innovation pipeline and meet business targets.
The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership, with a proven track record of establishing and growing a successful Quality function in a start-up environment.
Key Responsibilities- Ensure cGMP compliance against 21 CFR Parts 117, 110, 101, and 11
- Serve as subject matter expert and hold overall responsibility for implementation, direction, and coordination of the QA, QC, and Quality Systems functions
- Lead and manage regulatory and certification inspections, quality event investigations, and CAPA management
- Maintain 3rd party certifications, such as Safe Quality Food (SQF) and non-GMO certifications
- Lead, assess, mentor, and develop departmental associates and analysts
- Establish Quality strategy, policies, and define roles and problem solve
- B.A./B.S. or M.S. in Biology/Biological Sciences, Food Science, or related discipline
- 15+ years industry experience in Quality, with working experience with food/dietary supplements preferred
- Proven experience as Quality site head/leadership role, including establishing and growing a successful Quality function in a start-up environment
- Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA regulations and guidance documents
We offer a competitive salary range of $225,720-$250,800, as well as a comprehensive benefits package, including medical, dental, and vision coverage, commuter benefits, life and STD insurance, and a 401(k) plan with company match. We also offer flexible time off and equity in the company.
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