Ready to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!

Proclinical is seeking a Quality Project Manager to provide quality oversight for clinical supply activities, ensuring compliance with cGMP standards. You will play a key role in supporting the packaging, labelling, and global distribution of clinical finished goods, contributing to the timely delivery of materials for global trials.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Oversee batch release of clinical supplies, including review and approval of GMP documentation and issuance of batch certificates.
• Manage deviations and incidents, provide QA oversight for investigations, and approve related records.
• Handle change control processes for GCS (Global Clinical Supply) operations and documentation.
• Write, review, and approve GMP-relevant documents such as SOPs, CoAs, risk assessments, and packaging/labeling documentation.
• Support audits and inspections related to TRD GCS activities.
• Provide QA support for GCS operations, ensuring alignment with TRD QA standards.

Key Skills and Requirements:

• Advanced degree in life sciences or equivalent education.
• Proficiency in cGMP standards and QA processes, including batch release, deviation management, and change control.
• Hands-on experience with SAP materials management and batch record workflows.
• Familiarity with 1QEM is a strong asset.
• Strong communication and decision-making skills.
• Fluency in both German and English (oral and written).
• Experience in packaging and labeling operations or global clinical supply chains is a plus.
• Background in collaborating with CMOs or external partners is advantageous.
  

If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists 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.

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