Our client is a profitable, founder-led dietary supplement manufacturer looking for a Head of Quality. This is a critical, high-impact leadership role tasked with owning the company’s quality function, leading regulatory response efforts, and serving as the primary quality authority.
The organization is operating from a position of strength—with established revenue, committed investment in quality infrastructure, and direct executive support—yet requires an experienced operator to take full ownership of its Quality Management System (QMS) and regulatory posture.
**This position is On-site in San Diego, CA
Key Responsibilities:
- Lead and finalize the company’s response to FDA observations, including remediation planning, execution, and closure
- Own and continuously improve the Quality Management System (QMS) in alignment with 21 CFR Part 111 cGMP requirements
- Serve as the named quality signatory, with direct responsibility for batch release decisions
- Establish and enforce quality agreements with contract manufacturers, including clear ownership of release, deviations, and investigations
- Oversee supplier qualification, audits, and ongoing performance management
- Lead deviation, OOS (out-of-specification), and CAPA investigations, ensuring robust root cause analysis and sustainable corrective actions
- Build and refine core quality documentation, including: Component specifications (identity, purity, strength, contaminants), Master Manufacturing Records (MMRs), Batch Production Records (BPRs), Certificates of Analysis (CoA) review processes
- Manage complaints and adverse events, including regulatory assessment and reporting (e.g., MedWatch 3500A, SAER)
- Act as the primary liaison with regulatory agencies, including direct interaction with FDA investigators during inspections
- Partner cross-functionally with operations and supply chain to ensure compliant, scalable production across dosage forms
Required Skills, Experience, and Qualifications:
- 7+ years of quality experience within dietary supplements or nutraceuticals, operating under 21 CFR Part 111
- Demonstrated experience leading or co-leading a successful FDA Form 483 response, with observations closed to agency satisfaction
- Prior experience serving as a quality signatory during an FDA inspection (not solely a support role)
- Deep technical expertise in:
- Component specifications and testing requirements
- MMR/BPR development and execution
- CoA review and interpretation
- OOS investigations and CAPA systems
- Proven experience structuring and enforcing quality agreements with contract manufacturers
- Hands-on experience with supplier audits, third-party labs, and quality oversight across external partners
- Working knowledge of DSHEA Serious Adverse Event Reporting and MedWatch submission requirements
- PCQI certification or equivalent; HACCP strongly preferred
- Willingness to work on-site in San Diego
- Experience within a $20M–$200M revenue nutraceutical or consumer health company
- Comfortable operating in a lean, high-accountability environment (20–300 employees), rather than a large pharmaceutical organization
- Experience across multiple dosage forms, including capsules, tablets, and tinctures
- Practical familiarity with modern, lightweight QMS tools and systems, with a preference for adaptable solutions over heavily bureaucratic platforms
- A builder mindset with strong technical judgment and a bias toward action
Compensation: $160,000 - $190,000 plus bonus and benefits
If this sounds like the position you have been waiting for, please apply using the online application or the link below - all inquiries are strictly confidential. Our focus is to assist you to make your best next career move, and we will not use your information for any other purpose.
Kalon Executive Search is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. www.KalonSearch.com