The Director of Quality Assurance (QA) will lead the development and execution of quality strategies supporting clinical-stage and/or commercial products.
This role ensures compliance with global GxP regulations while operating in a fast-paced, innovation-driven setting.
The Director will continue to build scalable quality systems, support regulatory submissions, and provide QA oversight across clinical development, manufacturing, and external partnerships.

Requirements

Education Bachelor’s degree in Life Sciences (Biology, Biochemistry, Molecular Biology, etc.)
Advanced degree (MS, PhD) preferred
Experience 10–15 years in QA within biotech or biopharma
Strong experience in clinical-stage development and manufacturing
Proven leadership in a startup or high-growth biotech environment preferred
Core Competencies Expertise in GMP, GCP, GLP regulations and compliance
Strong experience with regulatory submissions (IND, BLA, MAA)
Ability to build systems from the ground up and scale with growth
Familiarity with digital QMS tools (e.g., Veeva)
Experience preparing for pre-approval inspections (PAI)

Benefits

Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.
A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
An unyielding commitment to always putting patients first.
A de-centralized model that enables our program teams to focus on advancing science and helping patients.
Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science.
A place where you own the vision – both for your program and your own career path.
A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game.
Access to learning and development resources to help you get in the best professional shape of your life.
Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs).
Flexible PTO
Rapid career advancement for strong performers.
Partnerships with leading institutions.
Commitment to Diversity, Equity & Inclusion.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GMPGCPGLPregulatory submissionsclinical-stage developmentmanufacturingquality strategiesquality systemspre-approval inspectionsdigital QMS

Soft Skills

leadershiporganizational skillscommunication skills