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, Regulatory Inspections, Quality Management System. Lead GCP quality activities. Oversee GCP quality activities”
Industry & Context.
Occasional international travel
What They're Looking For.
Must Have
Bachelor's degree or higher, Extensive experience in GCP Quality Assurance, Leadership experience at Director level, Hands-on experience planning audits, Hands-on experience conducting audits, Hands-on experience managing audits, Deep understanding of international regulatory requirements, Proven track record supporting regulatory inspections, Proven track record leading regulatory inspections, Experience managing interactions with global health authorities, Experience establishing quality management systems, Experience enhancing quality management systems, Experience maintaining quality management systems, Proficiency with electronic quality systems, Proficiency with eTMF platforms, Proficiency with quality documentation processes, Excellent communication skills, Excellent stakeholder management skills, Highly autonomous, Proactive, Organized, Capable of operating effectively in dynamic environment, Capable of operating effectively in resource-conscious environment
Nice to Have
Life Sciences degree preferred, Pharmacy degree preferred, Related advanced scientific qualifications preferred, Related healthcare qualifications preferred, Experience within neurology, Experience within neurodegenerative diseases, Experience within rare diseases, Experience within advanced clinical development programs, Familiarity with risk-based quality approaches, Familiarity with centralized monitoring methodologies, Familiarity with modern clinical quality strategies, Relevant professional certifications
What You'll Do.
Lead GCP quality activities
Oversee GCP quality activities
Ensure studies compliance
Ensure studies documentation
Ensure studies reporting
Serve as quality partner
Support protocol review
Support execution activities
Support reporting activities
Support continuous inspection readiness
Manage quality oversight of CROs
Manage quality oversight of vendors
Manage quality oversight of partners
Ensure alignment on quality standards
Ensure alignment on issue escalation
Ensure alignment on audit outcomes
Ensure alignment on corrective actions
Direct inspection readiness initiatives
Support regulatory authority inspections
Coordinate responses to inspections
Manage observation management
Follow-up on regulatory commitments
Maintain oversight of eTMF quality
Maintain oversight of protocol deviations
Maintain oversight of non-conformances
Maintain oversight of CAPA management
Maintain oversight of quality metrics
Maintain oversight of key performance indicators
Lead audits of clinical sites
Lead audits of vendors
Lead audits of service providers
Support audits of clinical sites
Support audits of vendors
Support audits of service providers
Review audit findings
Ensure effective remediation activities
Provide quality expertise for pharmacovigilance
Provide quality oversight for pharmacovigilance
Provide quality expertise for pre-clinical activities
Provide quality oversight for pre-clinical activities
Contribute to QMS development
Contribute to QMS continuous improvement
Represent Quality Assurance in teams
Represent Quality Assurance in forums
Promote quality culture
Mentor quality team members
Develop quality team members
Provide leadership across organization
Provide guidance across organization
How You'll Work.
Team & Collaboration
Cross-functional teams; Governance forums
Communication Scope
Translate regulatory requirements
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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