Mantell Associates
Mantell Associates are partnered with an CDMO organisation in their search for a Director of Quality to join their senior leadership team and build, lead and execute a quality strategy.
Director of Quality – Responsibilities:
- Oversee the organisation’s quality planning and execution processes
- Establish quality strategies to ensure CGMP compliance with international regulatory agencies regulations and expectations
- Provide leadership and functional management to Quality teams and ensuring adherence to current Good Manufacturing Practices (cGMPs) current Good Clinical Practices (cGCPs)
- Create 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 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
- Collaborate directly with regulatory authorities and clients to ensure the organisation is appropriately represented in all matters related to compliance and quality
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.