Mantell Associates are partnered with an Biologics organisation in their search for a Contract Qualified Person to join their release team and build, lead and execute a quality strategy and batch release. Please note this position requires someone to be based in The Netherlands for the duration of the contract.
QP - Responsibilities:
Act as Qualified Person for Large Molecules commercial medicinal 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
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.