Mantell Associates
Mantell Associates is partnered with a fast-growing, innovation-driven CDMO specialising in drug product development, who is searching for an experienced Senior QA Specialist – Supplier Audits.
This role is instrumental in strengthening supplier quality and compliance across a network of critical raw materials and component providers. Reporting to the QA Manager, you will be a key contributor to the Quality organization, responsible for leading supplier evaluations, audits, risk assessments, and ongoing supplier performance monitoring.
Senior QA Specialist – Responsibilities:
- Plan, execute, and lead supplier audits (on-site and remote) in accordance with cGMP, ISO standards, and internal procedures
- Evaluate supplier quality systems, processes, corrective actions, and risk controls to ensure compliance and robust supply continuity
- Prepare comprehensive audit reports, findings, and recommendations, and drive closure of audit observations with stakeholders
- Support supplier qualification activities, including documentation review, risk assessments, and technical evaluations
- Collaborate with Quality, Procurement, Regulatory, and Manufacturing teams to escalate supplier risks and implement mitigation strategies
- Maintain audit schedules, quality intelligence, and supplier performance metrics to support continuous improvement
- Serve as a subject matter expert on supplier quality expectations, training internal partners as needed
Senior QA Specialist – Requirements:
- Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related discipline. Advanced degree or quality certification (e.g., ASQ CQA) preferred
- Significant experience in supplier quality, audits, and quality systems within a pharmaceutical, biopharmaceutical, or CDMO environment
- Strong knowledge of cGMP, ICH, regulatory expectations, and quality risk management principles
- Demonstrated ability to lead supplier audits and effectively communicate findings to technical and operational stakeholders
- Excellent analytical, report writing, and interpersonal skills with a proactive, solutions-oriented mindset
- Ability to travel as required to support supplier audit activities (domestic and, occasionally, international)
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.