Start Date: ASAP

We are supporting a leading biotech organization and are looking for an experienced Director, GCP/GVP Quality & Compliance to strengthen the R&D Quality function.
This is a hands-on role focused on developing, implementing, and overseeing the GCP and GVP quality framework while ensuring inspection readiness and strong compliance across clinical development activities. The position plays a key role in driving quality oversight, managing risk-based audit programs, and supporting cross-functional teams and external vendors in maintaining high regulatory standards.
You will work closely with clinical development teams, quality leadership, and external partners to ensure compliant processes, effective risk management, and a strong quality culture across the organization.

Responsibilities

• Provide quality oversight for clinical development activities to ensure compliance with GCP and GVP requirements
• Act as the GCP Quality interface and provide expert guidance to internal stakeholders and project teams
• Ensure inspection readiness by identifying compliance gaps and ensuring CAPA actions are implemented effectively
• Collaborate with internal teams and external partners to implement global regulatory and industry compliance standards
• Manage and execute risk-based GCP/GVP audit programs
• Strengthen QA oversight of key CRO vendors, including development and monitoring of quality KPIs
• Plan, conduct, and report internal and external audits including vendors and clinical sites
• Identify and assess compliance risks and implement appropriate mitigation strategies
• Ensure timely follow-up and resolution of identified quality issues
• Develop, review, and implement Clinical QA SOPs and quality processes
• Support and lead continuous improvement initiatives within the Quality organization
• Support preparation and review of regulatory submissions to global health authorities
• Lead or support health authority inspections and related readiness activities
• Provide QA oversight of clinical systems such as eTMF, CTMS, and vendor quality systems to ensure compliance
• Deliver training on regulatory requirements and quality compliance topics
• Contribute to quality strategy, departmental objectives, and broader organizational goals while promoting a strong quality culture

Requirements

• Bachelor’s or Master’s degree in a scientific discipline
• 10+ years of experience within the pharmaceutical or biotech industry in Quality roles
• Extensive knowledge of GCP and working knowledge of GVP regulations
• Strong familiarity with international regulatory frameworks including FDA, EMA, MHRA and ICH guidelines (including ICH E6)
• Experience supporting or leading regulatory inspections
• Demonstrated experience managing audits and vendor oversight in clinical development
• Strong leadership and stakeholder management skills across cross-functional teams
• Excellent communication, presentation, and training abilities
• Highly organized with strong attention to detail and ability to manage multiple priorities in a fast-paced environment
• Ability to work independently while collaborating effectively across global teams
• Willingness to travel internationally when required