Head of Quality - CRDMO

Posted 08 March 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline Large Molecule
Contact NameNikhil Akkoo

Job description

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.

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 experience in management

  • Proven experience controlling 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.