Compliance Manager – Clinical Quality Assurance Oversight

🔥 1 minute ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

👻 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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Provide Clinical Quality oversight and support to 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 directions and recommendations for issue avoidance • Maintain continuous awareness and conduct periodic reviews 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 • Enable and facilitate Quality Risk Management • 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 • Drive support for Partnership Governance • 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 • In some cases, 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 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 GCP and regulatory requirements • Preferably working knowledge of pharmacovigilance requirements relevant to clinical trials, including ICH E2A and applicable FDA and EU safety-reporting requirements • Ideally, ability to recognize and escalate PV quality and compliance risks involving serious adverse event reporting, safety-data reconciliation, reporting timelines, and PV vendor or partner oversight • Ability to motivate and educate clinical study teams on clinical quality aspects • Capability to build effective relationships with internal and external stakeholders • Ability to translate quality culture and ways of working to study teams • Fully remote, ideally Central time zones • Relocation assistance is NOT provided

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • 0–25% travel may be required • Relocation assistance is NOT provided