Mantell Associates
Mantell Associates is currently partnered with a biopharma CDMO with a focus on advanced therapeutics and critical medicines. They are seeking a Chief Quality Officer to join their growing leadership team.
Chief Quality Officer – Responsibilities:
- Responsible for developing and leading the quality management and regulatory compliance strategy for the company. This includes overseeing quality assurance, quality control, and regulatory compliance for all biopharmaceutical products and manufacturing processes
- Ensure that all products meet the highest standards of quality and safety and that the company adheres to all local and international regulations
- Play a key role in leading continuous improvement initiatives within the company’s manufacturing and operational processes
- Lead the design, execution, and continuous improvement of the company’s quality management system (QMS) to ensure consistent product quality and operational excellence
- Oversee all quality assurance and control activities to ensure that manufacturing processes meet the highest standards of quality and safety
- Implement robust QA and QC processes that prevent defects and ensure product consistency
- Establish performance metrics for quality and ensure adherence to established GMP, ISO standards, and SFDA regulations
- Stay updated on regulatory changes and advise senior leadership on how to adapt to evolving regulations
- Lead continuous improvement initiatives to enhance manufacturing efficiency, reduce costs, and improve product quality
- Foster a culture of quality excellence and implement lean manufacturing practices to drive process improvements across all operations
- Lead, mentor, and develop the quality team, ensuring that they are equipped with the knowledge and skills to execute the company’s quality strategy
Chief Quality Officer – Requirements:
- Bachelor’s degree in Pharmaceutical Sciences, Biotechnology, Engineering, or a related field
- A Master’s degree or equivalent professional certification (e.g., Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar) is preferred
- Minimum of 15 years of experience in quality management within the biopharmaceutical, biotechnology, or healthcare industries, with at least 5 years in a senior leadership role
- Proven track record in implementing GMP, ISO 9001, and other quality management systems in a regulated environment
- Extensive knowledge of SFDA, FDA, and EMA regulations
- Expertise in quality assurance, quality control, regulatory compliance, and risk management within the biopharmaceutical industry
- Strong leadership and problem-solving skills, with the ability to drive continuous improvement initiatives
- Excellent communication and interpersonal skills, with the ability to work collaboratively across departments and with external partners
- Proficiency in quality management software and ERP systems
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.