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Compliance Manager
Thermo Fisher Scientific. Conduct complex internal and/or external audits for compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual obligations .
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Conduct complex internal and/or external audits for compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual obligations
- Identify issues affecting the quality or integrity of clinical research programs
- Determine root causes of non-conformance and develop strategies to address issues
- Perform technical document reviews and other GxP activities supporting clinical development programs
- Provide audit reports to management
- Plan and deliver quality services for contracted quality assurance audits, internal site audits, laboratory audits, and file audits
- Lead process and quality improvement initiatives
- Develop compliance-management tracking tools and materials and analyze trends
- Mentor less experienced staff
- Serve as project lead for group projects
- Create formal networks with key contacts across the department
Requirements
What you’ll need- Bachelor’s degree in life sciences, nursing, pharmacy, or related field
- 5+ years of clinical research experience, including at least 2 years in Clinical Quality, GCP Compliance, or related role
- Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectations
- Proven experience in CAPA, root cause analysis, and deviation management
- Ability to communicate complex compliance issues clearly and effectively
- Comfort working in a matrix organization and managing cross-functional customers
- Thorough knowledge of applicable GxP and appropriate regional regulations
- Extensive knowledge of the clinical trial process
- Excellent oral and written communication skills, including medical and scientific terminology
- Training/mentoring experience
- Strong attention to detail
- Problem-solving, risk assessment, and impact analysis abilities
- Strong leadership, organizational, and time management skills
- Strong digital literacy and ability to learn appropriate software
- Flexibility and adaptability
- Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Clinical quality systems experience such as Veeva Vault or TrackWise is a plus
- Veeva QMS experience is a plus
- An equivalency combining appropriate education, training, and/or directly related experience may be considered sufficient
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused workplace