About the Role:
Our client is seeking an experienced, hands-on Director of Quality Assurance to establish and lead the biologics Quality function from the ground up. This is a foundational, high-impact role for a quality leader who thrives in a fast-paced, resource-conscious start-up environment and can operate across the full spectrum of GxP quality — while helping shape the company's quality culture from an early stage of development. The ideal candidate has built and rolled out quality systems before, has direct experience providing biologics manufacturing quality oversight, and is equally comfortable operating as a strategic architect of the quality system and as a hands-on practitioner who reviews documents, conducts audits, and hosts inspections personally. Experience across drug substance, drug product, and device or combination products is highly valued.
Key Responsibilities:- Design, implement, and continuously improve a right-sized, phase-appropriate Quality Management System (QMS) tailored to an early-stage company, scaling processes as the pipeline advances from nonclinical through clinical development.
- Establish core quality infrastructure, including document control, deviation and CAPA management, change control, complaint handling, training, and vendor/supplier qualification programs.
- Serve as the company's primary quality leader, establishing and championing a strong culture of quality across all functions.
- Author, review, and maintain SOPs, quality policies, and controlled documents.
- Ensure documentation practices meet regulatory expectations and support data integrity (ALCOA+ principles).Develop and execute internal and external (vendor, CDMO) audit programs; conduct audits personally as needed.
- Lead inspection readiness activities and serve as the primary point of contact and host during FDA, EMA, or other health authority inspections.
- Manage audit findings, CAPAs, and follow-up activities through to closure.
- Provide quality oversight of drug substance and drug product manufacturing, testing, and release.
- Review and approve batch records, certificates of analysis, specifications, and other GMP documentation.
- Partner with CMC and Technical Operations on tech transfer, process validation, and comparability protocols.
- Establish quality oversight of raw materials, incoming components, and starting materials, including vendor qualification and material release processes.
- Negotiate and manage quality agreements with CDMOs, testing laboratories, and other GxP vendors.
- Support regulatory submissions with quality input, documentation, and review.
- Support quality oversight for device or combination product development where applicable, including design controls, risk management and design history file documentation
- Build and lead the Quality function as the company grows, including hiring and developing future quality staff and/or managing consultants and contractors.
- Partner cross-functionally with CMC, Regulatory, and executive leadership to embed quality thinking into all development activities.
- Report quality metrics, risks, and inspection readiness status to executive leadership and the Board as appropriate.
Qualifications:
RequiredBachelor's degree in a scientific, technical, or related discipline; advanced degree preferred.15+ years of progressive Quality Assurance experience in the biotech/pharmaceutical industry, including significant experience at the Director level or above.
Demonstrated, hands-on experience building and rolling out a Quality Management System from the ground up — including SOPs, document control, deviations/CAPA, change control, and training programs.
Proven experience with biologics manufacturing quality oversight.
Experience with CDMO manufacturing.
Direct experience hosting and/or leading regulatory inspections (FDA and/or other health authorities) and managing internal and external audit programs.
Experience working in a start-up or small-company environment, with a demonstrated ability to build processes operate across multiple areas of responsibility.
Strong working knowledge of GMP regulations; working knowledge of GLP strongly preferred.
Experience with drug substance and drug product quality oversight.
Excellent written and verbal communication skills, with the ability to author and review technical and quality documents.
Strong leadership and judgment, with the ability to operate independently while building consensus across functions.
Preferred:
Experience with medical device or combination product quality systems (design controls, ISO 13485, ISO 14971).Experience supporting IND/IMPD and BLA/MAA submissions. Experience scaling a quality organization through successive stages of clinical development (Phase 1 through pivotal/registration).
