Associate Director, Clinical Quality Assurance – Remote (East Coast Preferred)
About Us
Join a fast-growing, innovative global biotech at the forefront of developing life-changing therapies for patients worldwide. With a highly promising clinical pipeline and strong recent data, we are seeking an experienced Associate Director, Clinical Quality Assurance to lead GCP quality strategy, ensure global regulatory compliance, and drive inspection readiness across clinical programs.
Why Us?
- Patient Impact: Contribute to high-quality clinical programs that bring meaningful therapies to patients globally
- Strategic Influence: Serve as a key QA partner, shaping quality and compliance strategy across cross-functional teams
- Collaborative Culture: Thrive in a fast-paced, high-performing environment that values accountability, innovation, and continuous improvement
Who We Are Looking For
We are looking for a driven and experienced Clinical Quality Assurance professional with expertise in GCP compliance. You will bring strong inspection and audit experience, with the confidence to operate independently and influence stakeholders across global clinical development teams.
Role Responsibilities
As the Associate Director, Clinical Quality Assurance, you will:
- Provide strategic quality oversight across global clinical development programs
- Develop and execute risk-based audit programs across investigator sites, vendors, systems, and processes
- Lead and support regulatory inspections (FDA, EMA, MHRA), ensuring continuous inspection readiness
- Oversee audit activities and ensure compliance with internal SOPs and global regulatory requirements
- Partner with cross-functional teams to identify compliance risks and implement effective mitigation strategies
Key Qualifications:
- 10+ years of GCP Quality Assurance experience within Pharma or Biotech
- Proven experience supporting regulatory inspections and interacting with health authorities (FDA, EMA, MHRA)
- Strong hands-on experience in GCP audit management and oversight
- Experience across Phase I–IV clinical trials (Phase III preferred)
- Degree in Life Sciences or a related field
What We Offer
- Competitive Package: Attractive salary, performance bonus, and long-term incentives
- Career Growth: High-visibility role with clear progression and leadership opportunities
- Meaningful Work: Be part of a company delivering transformative, life-changing therapies
Get in Touch
If this opportunity is of interest, please reach out to Guled Samatar at Meet:
- Call: 646-582-3675
- Email: [email protected]