QA Project Leader for Drug Product

Proclinical is seeking a dedicated QA Project Leader to oversee compliance and customer quality agreement activities for drug products. This role involves establishing and negotiating quality agreements, acting as a point of contact for QA-related inquiries, and supporting manufacturing operations. The successful candidate will play a crucial role in cross-functional teams and customer meetings, ensuring effective execution of tasks related to drug product processes.

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:

• Supervise compliance and customer quality agreement activities.
• Establish and negotiate quality agreements with relevant stakeholders.
• Serve as the main contact for QA-related questions and complaints.
• Manage interactions involving changes, deviations, and technical complaints.
• Represent Quality Assurance in cross-functional teams and customer meetings.
• Support and approve project-specific risk assessments and regulatory gap assessments.
• Review and release product-specific documentation.
• Collaborate with QC-Project Leader and MSAT for new product introductions.
• Assess and approve quality records such as deviations and change controls.
• Author, review, and approve GMP-relevant documents and SOPs.
• Support continuous improvement programs for an effective Quality Management System.

Key Skills and Requirements:

• Strong understanding of quality assurance processes in pharmaceutical manufacturing.
• Experience in establishing and negotiating quality agreements.
• Ability to manage customer interactions and resolve QA-related issues.
• Proficiency in reviewing and approving technical documentation.
• Excellent communication and teamwork skills.
• Familiarity with GMP regulations and SOPs.

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

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.