Director, Quality - GCP (Contract)

Job overview:

The Director of Clinical Quality Assurance (GCP) serves as the enterprise GCP QA expert across the Compass organization, providing strategic leadership and oversight of clinical quality systems, audit programs, and compliance frameworks.

This role is accountable for ensuring the design, implementation, and continuous improvement of a robust, risk-based GCP Quality Assurance function that supports the full clinical development lifecycle. The Director will partner cross-functionally across R&D to ensure clinical trials are conducted in compliance with global regulatory requirements, with a strong focus on subject safety, data integrity, and inspection readiness.

The role operates with a high degree of independence, providing objective quality oversight and driving a culture of proactive quality and continuous improvement.

Reports to: VP, Quality.

Location: United Kingdom (Home-based or office-based/hybrid in our London office).

Duration: 6-month contract.

Roles and responsibilities 
(Include but are not limited to): 

Strategy & Leadership

• Define and execute the global GCP QA strategy aligned with organizational and clinical development objectives
• Build and scale GCP QA capabilities to support the clinical portfolio
• Maintain strong independence of the QA function while effectively influencing stakeholders across R&D
• Champion a proactive, risk-based quality culture across the organization

GCP Quality Systems & Governance

• Establish, maintain, and continuously improve GCP QA processes, procedures, and governance frameworks
• Ensure effectiveness of key quality systems (deviations, CAPA, change control, training, document management) in a GCP environment
• Provide expert guidance on regulatory expectations and evolving GCP requirements

Audit & Inspection Management

• Design and lead a comprehensive, risk-based GCP audit program covering: Investigator sites, CROs and vendors, Internal systems, processes, and databases
• Ensure audits are executed in compliance with global GCP regulations and internal standards
• Lead inspection readiness activities and act as a key Quality representative during regulatory inspections
• Oversee timely closure and effectiveness of audit and inspection CAPAs

Risk & Compliance Oversight

• Assess and interpret audit findings, deviations, and compliance risks with respect to: Subject safety, Data integrity, Regulatory impact
• Escalate critical and systemic risks to senior leadership with clear mitigation strategies
• Lead and oversee investigations into: Significant quality issues, Scientific misconduct., Serious breaches of GCP
• Ensure robust root cause analysis and sustainable CAPA implementation

Cross-Functional Partnership

• Act as the primary GCP QA advisor to R&D and external partners
• Collaborate closely with CROs and vendors to ensure quality standards are upheld and timelines are met
• Support governance forums and contribute to decision-making on clinical program risks and readiness

Training & Capability Building

• Develop and implement a fit-for-purpose GCP training strategy
• Ensure continuous development of internal capabilities and quality awareness

Metrics, Reporting & Continuous Improvement

• Define, track, and report key clinical quality metrics and trends
• Identify systemic issues and drive continuous improvement initiatives
• Provide clear and concise updates to senior leadership on quality performance and risk landscape

Candidate Profile:

• Extensive GCP QA experience across the full clinical development lifecycle (Phase I–IV)
• Proven leadership in designing and executing global GCP audit programs
• Deep knowledge of international GCP regulations and guidance (FDA, EMA, ICH)
• Strong experience managing regulatory inspections and complex compliance scenarios
• Demonstrated expertise in vendor oversight (CROs, labs, service providers)
• Strong understanding of GxP quality systems and processes (e.g., deviations, CAPA, audits, training, document control)
• Expertise in risk-based quality management and inspection readiness
• Ability to interpret complex regulatory requirements and translate into practical solutions
• Strategic thinker with the ability to operate at both tactical and operational levels
• Strong influencing and stakeholder management skills across a matrix organization
• Excellent communication skills with the ability to challenge constructively and diplomatically
• High level of integrity, independence, and sound judgment
• Proven ability to lead through complexity and drive results
• Bachelor’s degree in a scientific discipline (or equivalent experience); advanced degree preferred
• 15+ years of experience in clinical quality assurance within the pharmaceutical or biotech industry