Director / Senior Director, GCP Quality Assurance Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director / Senior Director, GCP Quality Assurance Lead based in the United Kingdom. This is a senior leadership opportunity for an experienced quality professional to oversee and strengthen quality assurance activities across global clinical development programs. The role plays a critical part in ensuring compliance, inspection readiness, and operational excellence throughout the clinical trial lifecycle. Working in a fast-paced and highly collaborative environment, you will partner closely with Clinical Development, Regulatory Affairs, Drug Safety, Biostatistics, and external partners to drive quality-focused decision-making. This position combines strategic leadership with hands-on execution, offering significant influence over quality systems, vendor oversight, and regulatory interactions. The successful candidate will help foster a proactive quality culture while supporting the advancement of innovative therapies with meaningful patient impact.

Accountabilities

• Lead and oversee GCP quality activities across global clinical development programs, ensuring studies are conducted, documented, and reported in compliance with applicable regulations, ICH guidelines, and internal procedures.
• Serve as the primary quality partner for clinical operations from study startup through study completion, supporting protocol review, execution, reporting activities, and continuous inspection readiness.
• Manage quality oversight of external CROs, vendors, and strategic partners, ensuring alignment on quality standards, issue escalation processes, audit outcomes, and corrective actions.
• Direct inspection readiness initiatives and support regulatory authority inspections, coordinating responses, observation management, and regulatory commitment follow-up.
• Maintain oversight of eTMF quality, protocol deviations, non-conformances, CAPA management, quality metrics, and key performance indicators.
• Lead or support audits of clinical sites, vendors, and service providers while reviewing audit findings and ensuring effective remediation activities.
• Provide quality expertise and oversight for pharmacovigilance and pre‑clinical activities, ensuring compliance with relevant GVP and GLP regulations and industry standards.
• Contribute to the development and continuous improvement of the Quality Management System (QMS), including SOPs, training programs, quality events, and regulatory intelligence activities.
• Represent Quality Assurance within cross‑functional teams and governance forums, promoting a culture where quality supports business and clinical objectives.
• Mentor and develop quality team members while providing leadership and guidance across the organization.

Requirements

• Bachelor’s degree or higher in Life Sciences, Pharmacy, or a related field; advanced scientific or healthcare qualifications are preferred.
• Extensive experience in GCP Quality Assurance within pharmaceutical, biotechnology, or CRO environments, including leadership experience at Director level or equivalent.
• Strong expertise across GCP, GVP, and GLP quality frameworks, with hands‑on experience planning, conducting, and managing audits.
• Deep understanding of international regulatory requirements and guidelines, including ICH standards, FDA regulations, EU Clinical Trial requirements, pharmacovigilance regulations, and GLP principles.
• Proven track record supporting or leading successful regulatory inspections and managing interactions with global health authorities.
• Experience establishing, enhancing, or maintaining quality management systems within growing or mid‑sized life sciences organizations.
• Proficiency with electronic quality systems, eTMF platforms, and quality documentation processes.
• Excellent communication and stakeholder management skills, with the ability to translate complex regulatory requirements into practical guidance.
• Highly autonomous, proactive, organized, and capable of operating effectively in a dynamic, resource‑conscious environment.
• Experience within neurology, neurodegenerative diseases, rare diseases, or advanced clinical development programs is advantageous.
• Familiarity with risk‑based quality approaches, centralized monitoring methodologies, and modern clinical quality strategies is considered a plus.
• Relevant professional certifications in quality assurance, clinical research, or regulatory affairs are desirable.

Benefits

• Competitive senior‑level compensation package.
• Fully remote work environment within Germany.
• Flexible working schedule with international collaboration across multiple time zones.
• Opportunity to play a key role in late‑stage global clinical development programs.
• Exposure to cross‑functional leadership and strategic decision‑making.
• International and collaborative work environment.
• Professional development and leadership growth opportunities.
• Occasional international travel for business, audits, inspections, and stakeholder meetings.
• Meaningful work supporting the development of innovative treatments for serious and underserved medical conditions.