Senior Director Quality

Mantell Associates; Köln; Vor Ort; EUR 100.000 - 130.000; Vollzeit

Zusammenfassung

A mid-size Pharmaceutical organisation is seeking a Senior Director of Quality to lead and execute their quality strategy. This role involves direct oversight of quality planning and execution, ensuring compliance with CGMP, and providing leadership to Quality teams to achieve both quality and business objectives.

Qualifikationen

• Proven experience with cGMPs.
• Strong working knowledge of GxP.
• Experience leading a Quality organisation.

Aufgaben

• Direct and oversee quality planning and execution processes.
• Establish quality strategies for CGMP compliance.
• Interface with regulatory authorities on compliance matters.

Kenntnisse

Good Manufacturing Practices (cGMPs)

GxP and quality systems

Leadership and management

Communication

Coaching and mentoring

Jobbeschreibung

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 [phone].