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 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.
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