Senior GCP Manager - Remote Opportunity in R&D QA

About the Role

We are seeking a Senior GCP Manager in R&D QA to join our dynamic team at Zealand Pharma. This remote opportunity allows you to leverage your expertise in Good Clinical Practice (GCP) quality and compliance to ensure high-quality clinical development. As a Senior GCP Manager, you will play a pivotal role in overseeing quality across our development activities, particularly in clinical trials.

What You'll Do

• Plan and conduct audits (e.g., GCP, Good Pharmacovigilance Practice (GvP), and Good Laboratory Practice (GLP)) and drive timely follow-up actions.
• Manage quality events including deviations, Corrective and Preventive Actions (CAPAs), and change cases in line with internal processes and applicable regulations.
• Support clinical trial teams with pragmatic, risk-based QA guidance—particularly in trial start-up and critical milestones.
• Contribute to inspection readiness and support regulatory inspections, including preparation, hosting support, and responses/follow-up.
• Lead and/or contribute to the GCP SOP Committee, ensuring consistency across development QMS documentation and training alignment.
• Handle suspected serious breaches related to clinical trials, including assessment, escalation, documentation, and coordination with relevant stakeholders.

Requirements

• Experience from clinical trial management and/or compliance/quality assurance within clinical development.
• Solid knowledge of GCP; familiarity with GvP and/or GLP is an advantage.
• Experience conducting audits, pre-qualification of suppliers, and supporting inspection readiness and regulatory inspections.
• Hands-on experience managing deviations, CAPAs, and change control in a regulated environment.
• Ability to apply risk-based thinking to balance compliant solutions with operational practicality.
• Strong communication skills and proven ability to collaborate effectively across functions and seniority levels.

Nice to Have

• Experience in a biotechnology or pharmaceutical company.
• Knowledge of regulatory requirements in clinical trials.
• Experience with electronic quality management systems (eQMS).

What We Offer

• Competitive salary and benefits package.
• Flexible remote work environment.
• Opportunities for professional development and growth.
• A collaborative and inclusive company culture.
• Engagement in innovative projects that impact patient care.

If you are ready to take on this exciting opportunity as a Senior GCP Manager - Remote, we encourage you to apply by February 15, 2026. We look forward to reviewing your application!