Head of Quality Assurance - CRDMO

Posted 11 May 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
DisciplineCell & Gene Therapy
Contact NameNikhil Akkoo

Job description

Mantell Associates is currently partnered with a rapidly growing and very successful CRDMO on their search for a Head of Quality, who will be an integral member of the site leadership team. 

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

Head of Quality - Requirements:

  • Bachelor’s degree or higher in a scientific area

  • Strong experience in leading Quality in a technical manufacturing environment

  • Strong understanding of C&GT manufacturing

  • Strong experience in management

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

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.