Compliance Manager – APAC

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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 for compliance with quality assurance processes, standards, regulatory guidelines, and client obligations • Provide consultation on GxP audit and inspection readiness, preparation, management, and follow-up • Serve as primary point of contact for client audit and inspection discussions • Support client audits and GxP regulatory authority inspections, including risk assessment, mitigation strategies, staff training, mock interviews, preparation activities, document review, hosting, facilitation, and follow-up • Lead, review, and approve audit and inspection reports • Support root-cause investigations and CAPA development; follow up on implementation, effectiveness checks, and evidence • Contribute to lessons learned and company-wide improvement initiatives • Develop and share compliance guidance, reference information, repositories, communication channels, policies, procedures, and quality management systems training • Lead process improvement initiatives and collaborate with cross-functional staff • Develop compliance activity tracking tools and analyze trends • Mentor less experienced staff and serve as project lead for group projects • Identify and resolve issues affecting clinical research program quality and integrity • 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 experience in management/leadership roles preferred • Extensive knowledge of GxP, with GCP required • Strong understanding of regional clinical research regulations, requirements, and guidelines, plus global guidelines/requirements • Experience with quality management systems and regulatory frameworks • Experience conducting internal audits and supporting, hosting, and managing client audits and GxP regulatory inspections across the region • Proven experience in root cause analysis • Strong problem solving, critical thinking, risk assessment, and impact analysis abilities • Detail-oriented and able to manage multiple changing priorities • 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

• Collaboration and development opportunities • Reasonable accommodation for individuals with disabilities • Equal employment opportunity