Compliance Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Execute intricate internal and/or external audits to ensure compliance with quality assurance protocols, standards, global regulatory requirements, and client contractual commitments.

• Detect issues that impact the quality or integrity of clinical research initiatives.

• Analyze root causes of non-compliance and formulate strategies to resolve identified issues.

• Conduct technical document assessments and other GxP activities that support clinical development initiatives.

• Prepare audit reports for management review.

• Organize and provide quality services for various audits, including contracted quality assurance audits, internal site audits, laboratory audits, and file audits.

• Drive process and quality enhancement initiatives.

• Create compliance-management tracking tools and resources, and evaluate trends.

• Guide and mentor less experienced team members.

• Act as the project leader for group initiatives.

• Establish formal networks with key stakeholders across the department.

⛳️ Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline.

• Over 5 years of clinical research experience, with a minimum of 2 years in Clinical Quality, GCP Compliance, or a similar role.

• In-depth understanding of ICH E6(R2/R3), EMA/MHRA/FDA requirements.

• Demonstrated expertise in CAPA, root cause analysis, and deviation management.

• Proficient in clearly and effectively communicating complex compliance matters.

• Comfortable working within a matrix organization and managing cross-functional stakeholders.

• Comprehensive knowledge of relevant GxP and applicable regional regulations.

• Extensive understanding of the clinical trial process.

• Exceptional oral and written communication skills, including familiarity with medical and scientific terminology.

• Experience in training and mentoring.

• Keen attention to detail.

• Strong problem-solving, risk assessment, and impact analysis skills.

• Excellent leadership, organizational, and time management abilities.

• High level of digital literacy and capability to learn necessary software.

• Adaptability and flexibility.

• Ability to qualify for and retain a corporate credit card with an adequate credit limit for business travel.

• Experience with clinical quality systems such as Veeva Vault or TrackWise is advantageous.

• Familiarity with Veeva QMS is a plus.

• A combination of relevant education, training, and/or directly related experience may be deemed sufficient.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• A workplace focused on scientific excellence.