Mantell Associates
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.