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.
