Senior Quality Assurance Specialist

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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.

• 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.

• 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).

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