Director of Quality Assurance - Medical Devices

Posted 10 August 2023
Salary Negotiable
Job type Full Time
Discipline Medical Devices
Contact NameSophie Packer

Job description

Mantell Associates is currently partnered with a Medical Devices organisation who is seeking a Director of Quality Assurance to join their team. You will be responsible for overseeing and managing the quality assurance function.

Director of Quality Assurance - Responsibilities:

  • Develop and implement a comprehensive quality assurance strategy and roadmap aligned with business objectives and regulatory standards

  • Lead and manage a team of quality assurance professionals, providing guidance, coaching, and performance evaluations

  • Establish and maintain robust quality management systems, processes, and procedures to ensure compliance with applicable regulations, guidelines, and standards

  • Collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure seamless integration of quality standards throughout the product life cycle

  • Conduct risk assessments and audits to identify potential quality issues, deviations, or non-conformities, and implement appropriate corrective and preventive actions

  • Stay abreast of evolving regulatory requirements and industry trends to proactively identify opportunities for process improvement and innovation

  • Foster a culture of quality and continuous improvement by organising training programs, workshops, and knowledge-sharing initiatives

  • Serve as the primary point of contact for quality-related matters during regulatory inspections, audits, and customer inquiries

Director of Quality Assurance - Requirements:

  • Proven experience in quality assurance roles within the pharmaceutical industry, with strong experience in a leadership position

  • Deep understanding of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, etc.), and quality management systems

  • Strong knowledge of pharmaceutical manufacturing processes, analytical techniques, and quality control methodologies

  • Excellent leadership and people management skills, with the ability to inspire and motivate teams toward achieving common quality goals

  • Exceptional problem-solving and analytical abilities, with a systematic approach to decision-making

  • Effective communication skills, both verbal and written, with the ability to interact confidently with internal and external stakeholders

  • Proven track record in successfully managing regulatory inspections and audits

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.