PHARMAFull-time
Compliance Manager - APAC
By Admin · Quality Assurance & Quality Control
REMOTE (IN)REMOTEPOSTED: 9/17/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE OVERVIEW
Lead GxP audit and regulatory inspection readiness and management across APAC, with responsibility for quality compliance, risk assessment, CAPA, audit reporting and continuous improvement across clinical research programs.
ROLE DEFINITION & RESPONSIBILITIES
- •Provide consultation on GxP audit and inspection readiness, preparation, management and follow-up
- •Serve as primary contact for client audit and inspection discussions
- •Support client audits and regulatory authority inspections including risk assessment, mitigation, training, mock interviews and inspection hosting
- •Lead, review and approve client, internal and GxP audit and inspection reports
- •Support root-cause investigations and CAPA development, implementation and effectiveness checks
- •Develop quality guidance, procedures, repositories and QMS training materials
- •Lead compliance process improvement initiatives and trend analysis
- •Mentor less experienced staff and lead group projects
Reporting Hierarchy: Reports to the relevant Quality/Compliance leadership within the Audits and Inspections organization; collaborates with project teams, clients, quality professionals, regulatory stakeholders and cross-functional teams across APAC and other regions
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree or equivalent relevant academic/vocational qualification
- 5+ years of quality assurance experience or equivalent combination of education, training and experience
- Extensive GxP knowledge with GCP required
- Understanding of regional clinical research regulations and global regulatory requirements
- Proven experience with quality management systems, internal audits, client audits and GxP regulatory inspections
- Proven root-cause analysis experience
- Strong risk assessment, critical thinking, problem-solving and communication skills
PREFERRED QUALIFICATIONS
- •Degree or formal study in Biology, Pharmacy or related field
- •1+ years of management or leadership experience
- •Veeva QMS experience
- •Experience mentoring staff and leading cross-functional projects
REQUIRED VERIFIED SKILLS
GxP
GCP
quality assurance
quality management systems
regulatory inspections
internal audits
client audits
audit readiness
inspection readiness
CAPA
root cause analysis
risk assessment
impact analysis
regulatory compliance
clinical research regulations
compliance management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health and wellness benefits, paid leave, professional development opportunities and other standard employee benefits
The source posting does not disclose compensation. No salary figures or bonus/equity amounts are provided.
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global science and technology company providing products, services and solutions that support laboratory research, diagnostics, clinical research and pharmaceutical development.
TEAM SIZE: 120,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
Culture: Thermo Fisher Scientific emphasizes scientific excellence, customer focus, collaboration, innovation, professional development and meaningful work supporting health and science outcomes.
EXPECTED CAREER ROADMAP
Potential progression includes Senior Compliance or Quality leadership roles, regional quality management, audit and inspection leadership, quality systems leadership and broader clinical quality or regulatory compliance management.
APPLICATION ADVISORY
Emphasize 5+ years of QA and GxP experience; demonstrate hands-on experience with regulatory inspections and client audits; highlight GCP knowledge and APAC/regional regulatory exposure; provide examples of root-cause analysis and CAPA effectiveness; mention leadership, mentoring and cross-functional project experience; include Veeva QMS exposure if applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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