Senior Director Quality - Biologics CDMO

Posted 31 July 2023
Salary Negotiable
LocationUnited States of America
Job type Full Time
DisciplineLarge Molecule
Contact NameNikhil Akkoo

Job description

Mantell Associates is partnered with a Biologics CDMO in their search for a Senior Director of Quality to join their senior leadership team and build, lead and execute a quality strategy.

Senior Director of Quality - Responsibilities:

  • Direct and oversee the organisation's quality planning and execution processes

  • Establish quality strategies to ensure CGMP compliance with international regulatory agencies regulations and expectations

  • Responsible for providing leadership and functional management to Quality teams and ensuring adherence to current Good Manufacturing Practices (cGMPs) current Good Clinical Practices (cGCPs)

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

  • Develop the quality policies strategy consistent with current regulatory expectations and ensure that the quality policies and objectives are clearly communicated, implemented, and maintained within the organisation

  • Establish and lead a Quality Management Review (QMR) process to ensure continued compliance with CGMP standards

  • Develop quality metrics and indicators to proactively identify and address quality systems or product-related issues

  • Interface directly with regulatory authorities and clients to ensure the organisation is appropriately represented in all matters related to compliance and quality

Senior Director of Quality - Requirements:

  • Proven experience with Good Manufacturing Practices (cGMPs)

  • Strong working knowledge of GxP and quality systems

  • 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

  • Experience with leading a Quality organisation including Quality Control (QC) and Quality Assurance (QA)

  • Excellent knowledge and previous collaboration with regulatory guidelines

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.