Director/Senior Director, GCP Quality Assurance Lead

Senior GCP Quality Assurance Lead - Permanent - Boston - Remote

Take the lead in delivering world-class QA across clinical development and advancing high-impact treatments.

Proclinical is seeking a Senior GCP QA Lead to support its clinical development portfolio focused on neurological and complex disease areas. This is a high-impact role within a collaborative, fast-paced environment dedicated to advancing innovative therapies for patients with unmet medical needs.

Primary Responsibilities:

Skills & Requirements:

Required

• Bachelor's degree or higher in Life Sciences, Pharmacy, or a related discipline
• Extensive experience in GCP Quality Assurance within biotech, pharmaceutical, or CRO environments
• Strong working knowledge of GCP, GVP, and GLP frameworks
• In-depth understanding of ICH guidelines and global regulatory requirements
• Proven experience leading or supporting regulatory inspections
• Experience with eTMF systems (e.g., Veeva Vault) and electronic QMS platforms
• Strong communication and stakeholder management skills
• Ability to work independently in a fast-paced, evolving environment

Desirable

• Experience within neurology, rare disease, or complex clinical programs
• Familiarity with risk-based and centralised monitoring approaches
• Relevant certifications (e.g., RQAP-GCP, RAC)
• Experience contributing to regulatory submissions
• Understanding of data integrity and computerised systems compliance

The Director/Senior Director's responsibilities will be:

GCP Quality Leadership

• Ensure clinical trials are conducted, documented, and reported in compliance with regulatory requirements, ICH guidelines, and internal procedures
• Serve as the QA lead across late-phase clinical programs, from protocol review through to study close-out
• Maintain oversight of outsourced clinical activities, partnering with CROs and vendors to ensure quality standards are met
• Oversee eTMF quality, manage protocol deviations and GxP non-conformances, and drive CAPA resolution

Inspection Readiness & Compliance

• Lead preparation for and management of global regulatory inspections (e.g., FDA, EMA, MHRA)
• Coordinate responses to inspection findings and ensure timely resolution of commitments
• Establish and track quality metrics and KPIs

Audit & Vendor Oversight

• Conduct and manage audits of clinical sites, vendors, and service providers
• Review audit findings and oversee CAPA implementation
• Support the development and review of Quality Agreements

GVP & GLP QA Support

• Provide QA oversight for pharmacovigilance systems and activities
• Support compliance with global safety and reporting regulations
• Contribute QA expertise to pre-clinical programs in line with GLP standards

Quality Systems & Collaboration

• Support the ongoing development and improvement of the Quality Management System (QMS)
• Contribute to SOP development, training, and quality processes
• Partner with Clinical, Regulatory, Safety, and other cross-functional teams
• Promote a proactive, quality-driven culture across the organisation
• Mentor junior team members where applicable

Compensation:

• $250 000.00 - $290 000.00 Per Annum

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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