Compliance Manager, Clinical Quality Assurance Oversight

🔥 12 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $95k - $140k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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 for 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 clinical trial studies or portfolios • Participate in regular partnership-level and ad hoc team meetings • Provide directions and recommendations for issue avoidance • Maintain continuous awareness and periodically review 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 Key Quality Indicators for emerging trends and potential risks • Promote compliance with client-specific quality-event, audit, and inspection-response requirements • Incorporate quality insights into operational lessons learned and promote awareness across the portfolio • Drive Partnership Governance support • 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 or equivalent and relevant formal academic/vocational qualification • 8+ years of previous compliance and quality experience, or comparable knowledge, skills, and abilities • Working knowledge of Good Clinical Practices (GCP) • CRO/Pharma industry experience required • In-depth knowledge of Clinical Trial-related FDA and EU regulations and ICH Guidelines • Strong knowledge of Clinical Development processes according to GCP and regulatory requirements • Proven experience building strong team and stakeholder relationships • Ability to motivate and educate clinical study teams on clinical quality aspects • Ability to translate quality culture and ways of working to study teams • Ability to communicate, receive, and understand information and ideas with diverse groups of people • Ability to work upright and stationary during typical working hours • Ability to use and learn standard office equipment and technology proficiently • Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities • Estimated travel of 0–25% • Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including drug screening

🏖️ Benefits

• Fully remote, home-based role • Variable annual bonus eligibility based on company, team, and/or individual performance • Relocation assistance is not provided