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Senior Associate at Mantell Associates - Quality Consultancy
Mantell Associates are partnered with a mid-size Pharmaceutical organisation 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.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance, Legal, and Management
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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