Head of Quality
Role summary
A rare disease biopharma company is seeking a Head of Quality to establish and manage its Quality Management System (QMS) in preparation for NDA submission and commercial launch. This senior, hands-on role requires deep expertise in GMP, CDMO oversight, and regulatory submissions, particularly for solid, semi-solid, or topical drug products. The Head of Quality will be the sole quality leader, responsible for all GxP activities, batch release, supplier management, and ensuring inspection readiness. Experience supporting at least one NDA/BLA and building a QMS independently is essential. Knowledge of clinical quality is a plus.
Description
About the Role
Small, late clinical‑stage rare disease company is preparing for NDA submission and commercial readiness and seeking a Head of Quality who will serve as the company’s sole quality leader. This individual will build and run a Quality Management System (QMS), oversee all GxP activities performed by external partners, and ensure the organization is inspection‑ready.
This is a highly visible and hands‑on role for someone who thrives in an agile environment, has deep experience with specialty biopharma solid or topical drug products, and CDMO oversight.
Key Responsibilities
Quality Leadership
- Serve as the company’s senior quality authority and primary decision-maker for all GxP matters.
- Build, maintain, and execute a lean, fit‑for‑purpose QMS appropriate for a small organization approaching NDA.
GMP Oversight & Batch Release
- Review and approve batch records, deviations, CAPAs, change controls, and investigations from CDMOs.
- Perform batch disposition and ensure compliance with specifications and regulatory commitments.
- Oversee stability programs and analytical method performance.
CDMO & Supplier Quality Management
- Function as the primary quality interface with CDMOs and testing labs.
- Conduct audits, manage quality agreements, and monitor ongoing compliance.
- Drive issue resolution and ensure partners are inspection‑ready.
NDA & Regulatory Support
- Lead all quality components of submissions.
- Prepare the company and CDMOs for pre‑approval inspections (PAIs).
- Support regulatory interactions and respond to FDA information requests.
Commercial Readiness
- Build quality systems to support commercial launch, including complaint handling, product release, and post‑market surveillance.
- Establish processes for ongoing GMP compliance in a small‑company environment.
Qualifications
Must‑Have
- Minimum of a BS in Biology, Chemistry, Engineering, or related discipline.
- MS degree preferred.
- 10+ years of branded/specialty pharmaceutical quality experience, including solid, semi‑solid, or topical product experience.
- Strong GMP background with hands‑on experience in batch review, deviations, CAPAs, and change control.
- Experience supporting at least one NDA or BLA.
- Demonstrated success overseeing CDMOs.
- Ability to build and run a QMS independently.
- Comfortable with domestic and international travel without limitations.
Nice‑to‑Have
- Experience with rare‑disease products or low‑volume commercial supply.
- Experience with accelerated approval or orphan‑drug programs.
- Prior experience preparing for or supporting a PAI.
- Although GMP is the primary focus, demonstrated knowledge and experience in clinical quality is highly desirable.
*TSP is an affirmative action/equal opportunity employer (Minorities/Females/Veterans/Disabled)*
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