Position Summary
The Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from start-up through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy and quality management systems and interact directly with the clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality and process improvement and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India) are desirable.
Key Duties and Responsibilities
- Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.
- Maintains current knowledge of ever-changing clinical quality guidance and regulations.
- Excellent communication and people skills to ensure a cohesive, collaborative teamwork.
- Demonstrated ability to implement and collaboratively drive company initiatives and policies.
- Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections by regulatory agencies highly preferred.
- Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).
- Successfully demonstrates ability to both conduct and manage site, internal GCP and vendor audits as well as direct and guide audit follow-up actions.
- Establish Quality and Cross-Functional SOPs and processes, and associated document controls.
- Serve as global document management system administrator.
- Manage and mentor direct reports.
- Organize cross-functional meetings between departments and Quality teams.
- Other duties as assigned.
Desired Education, Skills and Experience
- S. Degree in life sciences with advanced degree in a scientific discipline preferred.
- Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
- Minimum of two years of GCP auditing (e.g. clinical site and/or clinical vendor) experience preferred.
- Demonstrated ability to work with various cross-functional teams, including Clinical, Medical, Data Management, Medical Device/Drug Quality, Regulatory and CMC.
- Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
- Previous experience with oncology, combination drug-device studies, and/or multi regional clinical trial experience is a plus.
- Pharmacovigilance/Safety QA experience a plus.
- Medical Device GCP experience is a plus.
- Management of investigational drug / medical device is a plus.
- Electronic TMF, document, quality, and learning management systems experience.
- Strong organizational and project management skills.
- Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
- Professional working proficiency (IRL scale) or above in English.
- Willingness to travel up to 30%, but at times may be higher based on business needs.
