Contract Qp Biologics

Mantell Associates are partnered with a Pharmaceutical organisation in their search for a Contract Qualified Person focused on Biologics, to join their release team and build, lead and execute a quality strategy and batch release.
QP Biologics - Responsibilities : Act as Qualified Person for commercial products Responsible for all aspects release relating to the Quality organisation, including Quality Assurance (QA), Quality Control (QC) and Quality Management System (QMS) Provide leadership and strategy to ensure that all products/services and releases are aligned with quality standards, regulations (FDA and other notified regulatory bodies) and customer/regulatory requirements Work closely with the senior Operations team to transform and create a culture of compliance excellence - reporting to the top management on performances/improvements Onsite and Virtual Release Work closely with the Manufacturing, Regulatory Affairs and other departments to make suggestions, set objectives and execute solutions for improvements in processes and compliance QP - Requirements : Bachelor's degree or higher in a scientific area Previously registered as a QP Experience in Biologics Proven experience in management and leading Quality in a technical manufacturing environment Proven experience controlling Quality Management Systems (QMS) and with Good Manufacturing Practices (cGMPs) Must possess strong written and oral communication skills, ability to influence change/be a change agent, and be able to coach, mentor and train others Excellent knowledge and previous collaboration with regulatory guidelines Strong working knowledge of GxP and quality systems Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm.
For more information on this role, please contact us at +44 (0)20 3854 7700.