About the Company
Spherical Search has recently partnered with a well-established Analytical Testing and CRO services organisation specialising in the Pharmaceutical Industry. The company works with a broad range of pharmaceutical, biologics, and device organisations on a global scale. My client are a prominent player in the Inhalation industry, with our laboratory service provision in Wales, United Kingdom. They specialise in the development and testing of inhalation and nasal pharmaceutical products, collaborating closely with pharmaceutical companies to ensure product safety, efficacy, and regulatory compliance. They operate as a contract research and laboratory services organisation, delivering GMP and non-GMP services to a global pharmaceutical client base. The site operates within a regulated environment where quality, compliance, and scientific integrity are integral to all activities.
About the Role
The Quality Manager is responsible for the day-to-day management and delivery of Quality Assurance operations, ensuring that GMP and non-GMP activities are performed in compliance with regulatory requirements, company procedures, and client commitments. The role provides hands-on QA leadership across routine quality system activities, laboratory oversight, internal and supplier audit programmes, and inspection readiness. The post holder applies pragmatic, risk-based quality judgement appropriate to a contract laboratory operating mixed regulated and non-regulated activities. The Quality Manager acts as a senior quality practitioner and people manager, supporting operational teams, coaching staff in GMP and non-GMP expectations, and deputising for the Head of Quality as required.
Responsibilities
* Provide routine, hands-on QA oversight of GMP and non-GMP laboratory activities.
* Maintain effective day-to-day operation of the Pharmaceutical Quality System (PQS), including deviations, CAPAs, change controls, laboratory investigations, quality records and management of quality events.
* Ensure quality records are assessed, investigated and closed in a compliant, timely and risk-based manner.
* Perform or support batch, data and documentation review activities where required.
* Ensure QA oversight remains proportionate, risk-based and appropriate to the nature of the work undertaken.
* Lead, perform and report internal audits in accordance with the site audit programme.
* Plan and conduct supplier audits and supplier quality assessments, supporting supplier qualification and ongoing performance monitoring.
* Review and assess supplier quality documentation to support approval and continued use.
* Act as key Quality representative during client audits and regulatory inspections.
* Coordinate responses to audit observations, including oversight of CAPAs and effectiveness checks.
* Support maintenance and continuous improvement of the PQS, ensuring procedures are current, effective and consistently applied.
* Apply due diligence principles and CSV expectations across GxP systems and supporting tools.
* Ensure compliance with EU GMP (including Annex 11), FDA 21 CFR Part 210/211, FDA 21 CFR Part 11, and ICH Q8, Q9 and Q10.
* Line manage QA and direct reports and provide functional oversight and mentoring to operational teams.
* Support training, coaching and competency development across QA and operational teams.
* Promote clear, consistent and visible QA guidance in an approachable and collaborative manner.
* Identify and drive improvements to QA processes, systems and ways of working.
* Support or lead implementation and optimisation of electronic Quality Management Systems (eQMS).
* Actively promote a strong quality culture and continuous improvement mindset across the site.
Qualifications
* Preferably a first degree in a science, pharmacy or relevant discipline of grade 2:1 or above.
Required Skills
* Significant experience working in Quality Assurance within a GMP-regulated environment.
* Experience operating in a contract laboratory or service-based organisation conducting GMP and non-GMP activities.
* Demonstrable experience of conducting internal audits and supplier audits.
* Experience supporting and hosting client and regulatory inspections.
Preferred Skills
* Experience implementing or significantly enhancing electronic Quality Management Systems (eQMS).
EDUCATION, EXPERIENCE & RELEVANT SKILLS
* Strong working knowledge of EU GMP, FDA CFRs, Annex 11 and ICH Q8, Q9 and Q10.
* Sound understanding of data integrity and CSV principles.
* Proven ability to apply pragmatic, risk-based QA decision making.
* Approachable, credible and collaborative leadership style.
* Confident communicator with internal stakeholders, clients and regulators.
* Practical, solution-focused and calm under inspection conditions.
* Strong personal commitment to quality, compliance and continuous improvement.