Senior GCP Manager (Biotechnology, Remote)

Job summary

The role involves overseeing quality assurance in clinical development, focusing on Good Clinical Practice (GCP) compliance. The position requires a balance of hands-on detail-oriented work and risk assessment to ensure patient safety and data integrity during clinical trials.

Qualifications

• Experience in clinical trial management or compliance/quality assurance within clinical development.
• Strong knowledge of GCP; familiarity with Good Pharmacovigilance Practice (GvP) and Good Laboratory Practice (GLP) is a plus.
• Proven experience in conducting audits and supporting regulatory inspections.
• Hands-on experience with managing deviations, Corrective and Preventive Actions (CAPAs), and change control in a regulated environment.
• Ability to apply risk-based thinking for compliant and practical solutions.
• Excellent communication skills and ability to collaborate across various functions and seniority levels.

Responsibilities

• Plan and conduct audits related to GCP, GvP, and GLP, ensuring timely follow-up actions.
• Manage quality events, including deviations and CAPAs, in accordance with internal processes and regulations.
• Provide risk-based QA guidance to clinical trial teams, especially during trial start-up and key milestones.
• Contribute to inspection readiness and assist during regulatory inspections, including preparation and follow-up.
• Lead or participate in the GCP SOP Committee to ensure consistency in QMS documentation and training.
• Address suspected serious breaches in clinical trials, including assessment and coordination with stakeholders.

Skills

• Strong stakeholder management and communication skills.
• Ability to maintain a broad overview while diving deep into complex topics.
• A collaborative team player with a pragmatic mindset and strong integrity.

Education

• Relevant degree in life sciences or related field preferred.

Tools

• Familiarity with quality management systems and audit tools relevant to clinical development.