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.

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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.