Senior Director GCP Quality Assurance
2 months ago
My client is an exciting biopharmaceutical company advancing therapies for classical complement-mediated neuroinflammatory diseases. They are are seeking a Quality Assurance Director/Senior Director to lead their clinical Quality Assurance (cQA) program. This role involves developing and managing quality systems to ensure clinical trials comply with regulations and protocols, training staff, hosting regulatory inspections, and performing audits. This person will represent QA in a GCP-focused team setting, manage quality-related activities, and drive continuous process improvement.
Responsibilities:
- Provide strategic and technical leadership in Clinical Quality Assurance (GCP).
- Partner with clinical study teams to document quality event management, including CAPA plans.
- Oversee activities supporting regulatory submissions and inspections; lead GCP inspection readiness.
- Implement and monitor Quality Assurance Systems to ensure compliance with FDA, EU regulations, and ICH guidelines.
- Develop and implement Standard Operating Procedures (SOPs), quality manuals, policies, and related documents.
- Create and execute clinical quality risk management strategies.
- Develop and oversee training programs related to clinical quality assurance.
- Establish and monitor quality metrics and key performance indicators.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and pharmacovigilance.
- Perform internal and external audits to ensure compliance with GCP requirements.
- Track GCP compliance audit trends and present metrics-driven data to upper management.
- Lead or manage additional Clinical Quality Assurance (GCP) initiatives as needed.
Key Qualifications:
- Undergraduate or graduate degree in Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
- At least 10 years of experience in clinical quality assurance within the biotechnology or pharmaceutical industry.
- Experience with biologics is strongly preferred.
- Current and strong working knowledge of US Code of Federal Regulations, ICH Guidelines, and local government regulatory requirements.
- Expertise in creating and executing audit plans for service providers, clinical investigator sites, CSV audits, and process audits.
- Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards.
- Excellent verbal and written communication skills.
- Ability to lead cross-functional teams and prioritize work independently.
- Strong critical reasoning skills and attention to data quality control.
- Ability to manage multiple projects in a fast-paced environment and adapt to setbacks.
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