Company
Biotech
Director/SeniorDirector,GCPQualityAssuranceLead
Neural analysis suggests this role is
optimal for Director candidates.
“Director / Senior Director, GCP Quality Assurance Lead. Skills: GCP Quality Assurance, Audits, Regulatory Inspections, Quality Management System. Lead and oversee GCP quality assurance activities for global clinical development programs, ensuring compliance with regulations and internal procedures. Act as the primary quality partner for clinical operations, managing external CROs and vendors, and directing inspection readiness initiatives. Maintain oversight of eTMF quality, deviations, non-conf”
What You'll Achieve.
Ensure studies are conducted, documented, and reported in compliance with applicable regulations, ICH guidelines, and internal procedures. Promote a culture where quality supports business and clinical objectives. Meaningful work supporting the development of innovative treatments for serious and underserved medical conditions.
Industry & Context.
Risk-based quality approaches; Centralized monitoring
Fully remote work environment within Germany. Flexible working schedule with international collaboration across multiple time zones. Occasional international travel for business, audits, inspections, and stakeholder meetings.
What They're Looking For.
Must Have
Bachelor’s degree or higher in Life Sciences, Pharmacy, or a related advanced scientific or healthcare field. Extensive experience in GCP Quality Assurance within pharmaceutical, biotechnology, or CRO environments, including leadership experience at Director level or equivalent. 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. Excellent communication and stakeholder management skills, with the ability to translate complex regulatory requirements into practical guidance.
Nice to Have
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.
What You'll Do.
Lead and oversee GCP quality assurance activities for global clinical development programs, ensuring compliance with regulations and internal procedures.
Act as the primary quality partner for clinical operations, managing external CROs and vendors, and directing inspection readiness initiatives.
Maintain oversight of eTMF quality, deviations, non-conformances, CAPA, metrics, and KPIs, while also providing quality expertise for pharmacovigilance and pre-clinical activities.
How You'll Work.
Team & Collaboration
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.
Communication Scope
Stakeholder Management
Full Job Description
## 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
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