Senior Director, Clinical Quality Assurance
Senior Director, Clinical Quality Assurance
Location: U.S. (Remote, East-coast based preferred)
We're partnering with a late‑stage clinical biopharmaceutical company to hire a Senior Director, Clinical Quality Assurance to lead the global GCP quality program and provide quality oversight for late‑phase clinical development.
This is a highly visible leadership role responsible for ensuring global clinical trials - including Phase III studies - are inspection‑ready and compliant with ICH‑GCP, regulatory requirements, and internal quality standards.
What you'll be responsible for:
- Lead the global Clinical Quality Assurance (CQA) strategy and governance model
- Own and maintain a robust GCP Quality Management System
- Provide quality oversight for global Phase I-III clinical trials, with emphasis on Phase III
- Identify and mitigate GCP risks through risk‑based QA assessments
- Oversee vendor qualification, CRO oversight, and site quality activities
- Serve as the GCP SME and key partner to Clinical Operations, Regulatory, PV, Biostatistics, Data Management, and external partners
- Lead and support regulatory inspections (FDA, EMA, MHRA, PMDA, etc.) from a GCP perspective
- Drive audit strategy including CRO, investigator site, vendor, TMF, and internal audits
- Ensure effective CAPA development, implementation, and follow‑up
- Develop, review, and improve SOPs, quality metrics, and dashboards
- Promote a strong quality culture focused on transparency, inspection readiness, and continuous improvement
- Manage and develop a small clinical quality team, including internal staff and contractors
Background requirements:
- Bachelor's degree in a scientific or healthcare discipline (advanced degree preferred)
- 15+ years of experience in clinical quality, clinical development, or clinical operations
- 10+ years of hands‑on GCP / ICH clinical quality assurance experience
- Extensive experience supporting global Phase III clinical trials
- Strong auditing background; certifications a plus
- Deep knowledge of US and international GCP and regulatory expectations
- Direct experience leading or supporting global regulatory inspections
- Strong CRO oversight and vendor management experience
- Proven senior‑level communicator with excellent technical writing skills
- Comfortable operating in a fast‑paced, growing biotech environment
- Familiarity with eTMF, CTMS, and QMS platforms
- Willingness to travel up to ~25%
Why this role:
- Senior leadership role with direct impact on late‑stage development programs
- Opportunity to shape and mature the clinical quality function
- High exposure to executive leadership and global regulatory interactions
- Rare blend of strategic ownership and hands‑on clinical quality leadership
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.