Senior Quality Manager

About The Role

The post holder works closely with the Head of the Drug Control Centre to manage quality assurance and ensure compliance with university policies, UKAS ISO 17025, and WADA International Standard for Laboratories (ISL) 2021.

Based at the Institute of Pharmaceutical Science, the role reports to the Head of the Drug Control Centre and oversees quality assurance for the Drug Control Centre and King’s Forensics Mass Spectrometry Services.

Responsibilities

• Maintain comprehensive knowledge of ISO 17025 requirements and lead implementation and maintenance of the standard within the Drug Control Centre and KF‑MSS.
• Advise the Head and Deputy Director on accreditation requirements and implications of changes to quality standards.
• Oversee day‑to‑day ISO 17025 compliance, complete audits, initiate process improvement, and maintain validation records and risk logs.
• Investigate and report on root causes of complex or systemic deviations, complaints or quality system failures, identifying corrective and preventive actions.
• Work with the Head to implement a risk‑based internal audit programme that covers all ISO 17025 and WADA ISL specifications.
• Lead the Quality Assurance team, ensuring meticulous attention to detail and continuous compliance with ISO 17025.
• Collaborate with laboratory staff, accreditation bodies and stakeholders to identify improvement areas and evaluate quality processes, including training effectiveness.

Essential Criteria

• Relevant undergraduate or postgraduate qualification in a natural or life science, or equivalent experience.
• Experience working within a laboratory quality framework, including SOPs and document control.
• Experience with quality assurance structures and methods relating to method validation.
• Qualifications and documented training in ISO 17025.
• Experience running a risk‑based internal audit programme.
• Demonstrated analytical and problem‑solving skills, including root‑cause analysis and implementation of corrective actions.
• Strong communication skills to convey complex, specialist information to staff.
• Knowledge of document control, record‑keeping and monitoring KPIs, lists of substances, validation records and risk logs.

Desirable Criteria

• Practical experience of root‑cause analysis.
• ISO 17025 internal audit training.
• Experience working with a WADA‑accredited laboratory and knowledge of WADA ISL 2021.

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