Compliance Manager

🔥 0 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• Conduct complex internal and/or external audits for compliance with quality assurance processes, standards, global regulatory guidelines, and client contractual obligations • Identify issues affecting the quality or integrity of clinical research programs • Determine root causes of non-conformance and develop strategies to address issues • Perform technical document reviews and other GxP activities supporting clinical development programs • Provide audit reports to management • Plan and deliver quality services for contracted quality assurance audits, internal site audits, laboratory audits, and file audits • Lead process and quality improvement initiatives • Develop compliance-management tracking tools and materials and analyze trends • Mentor less experienced staff • Serve as project lead for group projects • Create formal networks with key contacts across the department

🎯 Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field • 5+ years of clinical research experience, including at least 2 years in Clinical Quality, GCP Compliance, or related role • Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectations • Proven experience in CAPA, root cause analysis, and deviation management • Ability to communicate complex compliance issues clearly and effectively • Comfort working in a matrix organization and managing cross-functional customers • Thorough knowledge of applicable GxP and appropriate regional regulations • Extensive knowledge of the clinical trial process • Excellent oral and written communication skills, including medical and scientific terminology • Training/mentoring experience • Strong attention to detail • Problem-solving, risk assessment, and impact analysis abilities • Strong leadership, organizational, and time management skills • Strong digital literacy and ability to learn appropriate software • Flexibility and adaptability • Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel • Clinical quality systems experience such as Veeva Vault or TrackWise is a plus • Veeva QMS experience is a plus • An equivalency combining appropriate education, training, and/or directly related experience may be considered sufficient

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace

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