Director, Clinical Compliance (GCP)

Proclinical is seeking a dedicated and proactive Director of Clinical Compliance. This role focuses on establishing and implementing a Quality Strategy for clinical development activities. The successful candidate will ensure all work is in agreement with regulatory requirements and will adherence to Good Clinical Practices. This role also involves leading a team of QA personnel across various locations, promoting a culture of transparency and proactivity.

This role can be a fully remote working role within the United Kingdom, or alternatively can be a hybrid working role based in Mainz, Germany.

Responsibilities:

• Provide strong QA leadership, fostering organizational awareness and interdepartmental collaboration.
• Implement the Clinical Development Quality Plan within the development portfolio.
• Provide robust quality oversight in various areas, including risk detection and remediation.
• Offer guidance on day-to-day questions arising from Clinical trials deliverables.
• Collaborate with Clinical Development Operations on initiatives relevant to outsourced activities.
• Support inspection preparation and facilitation in collaboration with other QA groups.
• Manage follow-up activities for audits and inspections, including CAPA preparation.
• Lead a team to ensure a unified approach to proactive support for clinical trials.

Key Skills and Requirements:

• Experience in a GCP Environment within the Pharmaceutical or CRO Industry.
• In-depth knowledge of worldwide regulations (including FDA, EMA) related to clinical development and post-approval.
• Experience in Quality functions such as auditing/compliance.
• Academic degree in Life Science (advanced degree preferred).
• Experience managing global communities.

Interested or know someone who might be? Reach out to ­­­­Josh Godden using the following:

✉️ j.godden@proclinical.com

📞 0203 854 0101 (5324)

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.