QC Process Team Leader - Bioassay

Ipsen Pharma

Wrexham, United Kingdom

About the role

We are pleased to announce an excellent opportunity for a QC Process Team Leader – Bioassay, within our QC and Quality function due to internal mobility.

This position will lead and oversee the development of a highly adaptable, proficient, and customer-oriented team.

Responsibilities include delivering QC CBA testing and services within agreed timelines to support batch release.

The role also involves establishing and agreeing on Key Performance Indicators (KPIs) to monitor performance and identify opportunities for enhanced customer service. Furthermore, the position requires establishing and maintaining processes for the sustainable delivery of QC CBA testing services while driving continuous improvement in performance and service over the long term.

The QC Process Team Leader – Bioassay will serve as the main contact for communication and coordination with external CBA testing partners.

What you will be doing…

Ensure all QC CBA data generated both internally and externally (at testing partners) is scheduled reviewed and reported within agreed business lead times;
Maintain and manage the day-to-day relationship with external testing partners. Also, to maintain a holistic overview of all locations to ensure there is no divergence;
Provide CBA support to Regulatory Submissions (including response to questions and post-marketing commitments) and Inspections;
Oversee and coordinate investigations in response to Out of Specification/Out of Trend results within company lead times;
Maintain compliant documentation of associated QC CBA procedures, specifications and policies;
Maintain all associated CBA equipment in a qualified, compliant state;
Trouble shoot assays and challenge ways of working to seek continuous improvement;
Actively participate in internal and external audits/inspections;
Establish highly effective working relationships with internal customers and stakeholders;
Ensure training of individuals within team to maintain high level of expertise and skills provided;
Develop technical skills of individuals to improve robustness, flexibility and efficiency of team;
Recruit and manage personnel within team.

What are we looking for...

Degree in Biology, Biochemistry or related scientific discipline;
Relevant experience working in a QC cell-based assay role;
Ability to assess different customer demands and make business priority calls to support batch release;
High Customer focus, with understanding of differing internal customer needs and timelines;
Strong people manager with the ability to motivate, empower and grow a team;
Detailed understanding of cell-based assay techniques, GMP and regulatory requirements (with relation to cell-based assay testing);
Experience of working in a GMP Environment.

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