探花合集

探花合集 is seeking a dedicated leader to head the Commercial and Batch Release team. This role focuses on ensuring robust compliance with batch release processes and fostering strong partnerships across various teams to support product portfolio expansion. You will play a key role in aligning quality objectives with business goals and driving innovation in operational practices.

Responsibilities:

• Oversee and motivate the Commercial and Batch Disposition teams to achieve excellence.
• Establish and monitor quality and business objectives for batch release performance.
• Support global expansion efforts and new product launches in collaboration with TechOps.
• Ensure compliance with Marketing Authorization Holder (MAH) and readiness for regulatory inspections.
• Continuously improve the Quality Management System (QMS) by benchmarking industry standards.
• Design and execute a compliance framework for batch release processes.
• Drive digital transformation of batch release processes to enhance efficiency and compliance.
• Create and implement Standard Operating Procedures as an author, reviewer, and approver.

Key Skills and Requirements:

• Degree in a relevant field, preferably a PhD or Masters in pharmacy or engineering.
• Certification as a Qualified Person is desirable.
• Strong skills in motivating and coaching teams on quality priorities.
• Excellent organizational, interpersonal, and stakeholder management skills.
• Strong analytical and problem-solving capabilities.
• Proficient in scientific writing and reporting.
• Extensive knowledge of GMP within a biopharmaceutical context.
• Familiarity with FDA, EU, PMDA regulations, and ICH Guidelines.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@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.

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