Compliance Manager, Clinical Quality Assurance Oversight

🔥 28 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide Clinical Quality oversight and support of clinical study teams • Serve as the dedicated, single point of Quality contact for the client • Partner with Operations to establish a consistent Quality culture across studies or portfolios • Participate in regular partnership-level and ad hoc team meetings • Provide direction and recommendations for issue avoidance • Maintain continuous awareness and periodic review of QE, SSM, SB, sPIP, audit, and inspection activities • Escalate appropriately to Client Quality, Quality Partner, Strategic Alliance Lead, bPL, PDL, or OD to minimize client impact and improve outcomes • Prepare and analyze QA-related KQIs for emerging trends and potential risks • Partner with Clinical Operations and PV to identify, assess, and mitigate risks to participant safety and reporting compliance • Review trends in SAE reporting timeliness, safety-data reconciliation, and PV vendor performance, and support follow-up actions • Promote compliance with client-specific requirements related to quality events, audits, and inspection responses • Incorporate quality insights into operational lessons learned and promote awareness across the portfolio • Co-chair Joint Quality Councils and contribute to other governance meetings • Present quality metrics and trends and discuss potential resolutions with relevant stakeholders

🎯 Requirements

• Bachelor's degree is required • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • 8+ years of comparable experience, or equivalent combination of education, training, and experience • Working knowledge of GCP is required • Proven experience in building strong relations is required • Experience working with CRO and/or Pharma companies is required • Preferably experience partnering with PV or Drug Safety teams in clinical development, including support for safety-reporting processes and follow-up of PV-related quality events, audit findings, or corrective and preventive actions • In-depth knowledge of Clinical Trial-related FDA and EU regulations and ICH Guidelines • Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements • Preferably working knowledge of pharmacovigilance (PV) requirements relevant to clinical trials, including ICH E2A and applicable FDA and EU safety-reporting requirements • Ideally able to recognize and escalate PV quality and compliance risks involving serious adverse event (SAE) reporting, safety-data reconciliation, reporting timelines, and PV vendor or partner oversight • Ability to motivate and educate the clinical study team on clinical quality aspects • Capable of building effective relationships with internal and external stakeholders • Ability to translate quality culture and ways of working to study teams • Relocation assistance is not provided

🏖️ Benefits

• Fully remote work arrangement • 0–25% travel may be required

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