QA Compliance Manager – Clinical Trials
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Job Description
QA Compliance Manager overseeing GxP audits, regulatory inspections, and CAPA activities for Thermo Fisher Scientific’s clinical research programs across APAC.
Responsibilities:
- Manage all aspects of GxP audits and Regulatory Authority inspections for the company, investigator sites, and clients
- Lead and/or review complex internal and external audits and inspections
- Consult project teams and clients on GxP audit and inspection readiness, preparation, management, and follow-up
- Serve as the primary contact for client audit and inspection discussions
- Support client audits and GxP regulatory authority inspections, including risk assessment, mitigation strategies, staff training, mock interviews, documentation review, hosting, facilitation, and post-inspection follow-up
- Lead, review, and approve client, internal, and GxP audit and regulatory inspection reports
- Investigate root causes of findings and non-conformances and develop CAPAs
- Follow up on action implementation, effectiveness checks, and supporting evidence
- Contribute to lessons learned and company-wide improvement initiatives
- Develop and share policies, procedures, guidance documents, repositories, communication channels, and quality management systems training
- Lead process improvement initiatives and collaborate with cross-functional staff
- Develop compliance-management tracking tools and analyze trends
- Mentor less experienced staff and serve as project lead for group projects
- Identify and resolve issues affecting the quality or integrity of clinical research programs
- Prepare and present audit findings and related information at departmental, internal operations, and client meetings
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 5+ years of quality assurance experience, or equivalent combination of education, training, and experience
- 1+ years of management/leadership experience preferred
- Biology, Pharmacy, or related field preferred
- Extensive knowledge of GxP, including required GCP knowledge
- Strong understanding of regional clinical research regulations, requirements, and guidelines, plus applicable global guidelines/requirements
- Experience with quality management systems and regulatory frameworks
- Experience conducting internal audits and supporting, hosting, or managing client audits and GxP regulatory inspections across the region
- Proven root cause analysis experience
- Strong problem-solving, critical-thinking, risk-assessment, and impact-analysis abilities
- Exceptional verbal, written, and presentation skills, including medical and scientific terminology
- Strong negotiation and conflict-management skills
- Ability to mentor and direct staff and work independently or in a team environment
- Strong organizational and time-management skills; flexibility and ability to multitask and prioritize complex workloads
- Advanced proficiency in Microsoft Office Suite and compliance-related software
- Veeva QMS experience is a plus
Benefits:
- Global team resources supporting individual career goals
- Collaboration and professional development opportunities
- Mentoring and development as part of the everyday experience
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