Jobgether
Director / Senior Director, GCP Quality Assurance Lead
TLDR
Leads GCP quality activities across global clinical development programs, ensuring compliance, inspection readiness, and strategic supplier oversight.
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.
- 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.
- 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.
Requirements
Benefits
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Benefits
Flexible Work Hours
Flexible working schedule with international collaboration across multiple time zones.
Remote-Friendly
Fully remote work environment within Germany.
Jobgether runs the largest remote job platform, effectively linking job seekers with over 200,000 flexible and remote opportunities that match their unique skills and preferences. Our focus is on enhancing the hiring process, ensuring efficiency while prioritizing the candidate experience, particularly in the growing health and wellness sector.
- Founded
- Founded 2020
- Employees
- 11-50 employees
- Industry
- Professional Services
Quality Assurance (QA) Lead