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

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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 lifecycle

• 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 organizing 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

Qualifications and Skills:

• Proven experience (8+ years) in quality assurance roles within the pharmaceutical industry, with at least 3 years 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

• Relevant certifications

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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.