Compliance Manager - APAC

About the role

As a Compliance Manager within Thermo Fisher Scientific's Audits and Inspections team, you will manage all aspects of GxP audits and Regulatory Authority inspections for the company, investigator sites, and clients across the APAC region. Day-to-day responsibilities include leading and reviewing complex internal and external audits, serving as the primary point of contact for clients, supporting inspection readiness and follow-up, investigating root causes, developing CAPAs, mentoring staff, and driving process improvement initiatives. This is a full-time, remote role based in India with a standard Monday-Friday schedule.

What you’ll do

• Provide consultation to project teams and clients on GxP audit and inspection readiness, preparation, management, and follow-up activities
• Serve as the primary point of contact for audit and inspection-related discussions with clients
• Support client audits and GxP regulatory authority inspections of the company, investigator sites, and sponsors, including risk assessment and mitigation strategies, training of involved staff and con
• Lead, review, and approve reports for a variety of client, internal, or GxP audits and regulatory inspections
• Support project teams in investigating root causes of findings/non-conformances and in developing CAPAs to address identified issues; follow up on action implementation, effectiveness checks, and the
• Contribute to lessons learned discussions and participate in company-wide improvement initiatives
• Develop and effectively share guidance and reference information, repositories, and communication channels including policies, procedures, guidance documents, or quality management systems training
• Lead process improvement initiatives and collaborate with a variety of cross functional staff to ensure appropriate execution and completion and continuous improvement

What you’ll bring

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification (preferred fields: Biology, Pharmacy, or related)
• 5+ years of quality assurance experience providing the knowledge, skills, and abilities to perform the job, or equivalent combination of education, training, and experience
• Extensive knowledge of GxP, with GCP required, plus strong understanding of applicable regional clinical research regulations, requirements, and guidelines and applicable global guidelines/requirement
• Proven expertise and experience in quality management systems and regulatory frameworks, conducting internal audits, and supporting, hosting/managing client audits and GxP regulatory inspections acros
• Proven experience in root cause analysis
• Strong problem solving, critical thinking, risk assessment, and impact analysis abilities
• Exceptional communication (verbal and written) and presentation skills, including appropriate use of medical and scientific terminology
• Advanced proficiency in Microsoft Office Suite and compliance-related software

Nice to have

• 1+ years of experience in management/leadership roles
• Veeva QMS experience

Skills

Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualification