Mantell Associates
Mantell Associates are partnered with an CDMO organisation in their search for an Associate Director of Quality Assurance to join their senior leadership team and build, lead and execute a quality strategy.
Associate Director of Quality Assurance – Responsibilities:
- Responsible for all aspects of 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 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
- Ensure the site QMS is aligned with regulatory requirements and International Quality Standards
- Work closely with the Manufacturing, Regulatory Affairs and other departments to make suggestions, set objectives and execute solutions for improvements in processes and compliance
- Oversee team members and ensure performance levels meet corporate, Quality and business objectives
Associate Director of Quality Assurance – Requirements:
- Bachelor’s degree or higher in a scientific area
- 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.