Thermo Fisher Scientific

Senior Compliance Manager

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: Remote • North Carolina • 🇺🇸 United States

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Job Level

Senior

About the role

  • Identify systemic gaps in quality/compliance by conducting internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites
  • Prepare detailed audit reports to communicate observations
  • Maintain knowledge of GMPs and be aware of revised or emerging quality regulations
  • Promote positive Quality and leadership behaviors
  • Participate in ad-hoc quality compliance projects related to auditing

Requirements

  • Minimum of 10 years professional working experience in Pharmaceutical Industry
  • At least 5 years aggregate experience performing audits for GMP, ISO or ICH
  • Hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections
  • Must be an expert Quality compliance auditor
  • Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment
  • Experience in sterile manufacturing and aseptic practice is desired
  • Professional auditor training/certification by an organization recognized within the pharmaceutical industry (e.g. IRCA, ASQ)
  • Strong foundation of pharmaceutical manufacturing and laboratory operations
  • Strong communication skills including listening, judgment, problem management, ability to lead teams in a sophisticated and global environment
Benefits
  • Health insurance
  • 401(k) matching
  • Paid time off
  • Remote work options
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GMPISOICHauditingdata integritysterile manufacturingaseptic practicequality compliancepharmaceutical manufacturinglaboratory operations
Soft skills
communicationlisteningjudgmentproblem managementleadership
Certifications
IRCAASQ
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