​Mantell Associates is currently partnered with an incredibly exciting CRDMO on their search for a Head of Quality, who will be an integral member of the site leadership team.

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Head of Quality - Responsibilities:

• Responsible for aspects of the site’s Quality organisation - 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 leadership team to transform and create a site 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

• Direct and oversee the quality planning and execution processes

• Develop short and long-term plans to achieve both quality and business objectives for the organisation

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Head of Quality - Requirements:

• Bachelor’s degree or higher in a scientific area

• Strong experience in leading Quality in a technical manufacturing environment

• Strong experience in management

• Proven experience controlling Quality Management Systems (QMS) supporting ISO 9001, and ISO 13485 certifications, FDA Regulations

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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.