Director / Senior Director, GCP Quality Assurance Lead

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.

Diese Anzeige stammt von ats_lever. Originalanzeige ansehen ↗