Senior Director Quality Lead
1 day ago
Pendulum is a pioneering company that is leading a global revolution to improve physical and mental health by understanding, restoring, and enhancing the human microbiome.
Our research has shown that the microbiome plays a critical role in various aspects of our lives, including metabolism, diabetes, longevity, weight loss, immune systems, cancer prevention, feelings of well-being, inflammatory bowel disease, and healthy skin.
As a Senior Director, you will oversee the Quality Site Head and lead Pendulum's in-house quality team, ensuring compliance with regulatory requirements and delivering the innovation pipeline.
You will establish the quality strategy, policies, and procedures to ensure compliance with all regulatory, company, and customer requirements.
This role requires a strong leader with strategic expertise, effective leadership skills, and a hands-on approach to build the quality function at Pendulum.
Key Responsibilities:- Ensure cGMP compliance against 21 CFR Parts 117, 110, 101, and 11
- Serve as subject matter expert for QA, QC, and Quality Systems functions
- Lead and manage regulatory and certification inspections
- Quality event investigations and CAPA management
- Change management and document/records management
- Risk management
- Data integrity
- Quality metrics reporting/Management Review
- Technology transfer
- Stability program
- Training program
- 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
- $225,720-$250,800 salary range
- Medical, Dental, and Vision benefits
- Commuter Benefits
- Life & STD Insurance
- Company match on 401(k)
- Flexible Time Off (FTO)
- Equity
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