Withers & Wagg are delighted to be exclusively retained by a clinical stage biotechnology company working in rare disease. Of the 10,000 rare diseases recognised globally, fewer than 5% have an approved treatment. The company uses artificial intelligence to find new uses for drugs that already exist, which shortens development timelines considerably and carries a lower risk profile than starting from a new molecule. The pipeline covers multiple rare disease programmes with the lead asset now in clinical development, supported by partnerships with large pharmaceutical companies and backing from international venture investors.

The Role

This is the sole quality appointment in the business, spanning both GCP and GMP. The postholder owns the quality management system outright, providing strategic oversight alongside hands on execution, and acts as the person the leadership team relies on for quality judgement.

On the clinical side the focus is ensuring research conducted internally and by vendors meets GCP standards and international regulation, delivering the annual audit plan and supporting risk management and training. On the manufacturing side the focus is ensuring investigational product meets GMP standards through batch record review, internal, external and supplier audits, deviation and CAPA investigation, documentation control and release.

It suits someone who is comfortable being the only quality voice in the room, who can translate regulation into workable procedure, and who wants proximity to decision making in a lean and fast moving company.

Key Responsibilities

• Own, maintain and improve the quality management system, including training delivery and tracking, change control, deviations, CAPAs and risk assessments.

• Develop and maintain company procedures in line with ICH GCP and GMP expectations across the territories of operation.

• Prepare and execute the annual audit plan, covering internal compliance, investigational sites and third party vendors, and ensure vendors maintain qualification.

• Maintain inspection readiness at all times, conduct self inspections and act with Regulatory Affairs as the primary contact for MHRA, FDA and EMA inspections.

• Review and jointly approve quality technical agreements and batch records, and ensure proper control and archiving of quality related data.

• Approve or reject raw materials, intermediates and finished product, verifying batch documentation and specifications against the approved versions filed with health authorities before release.

• Investigate out of specification results, deviations and trends, and lead root cause analysis.

• Work with the CMC Director on change control and with Regulatory Affairs to keep manufacturing and clinical activity aligned to current filings including IND, CTA and MAA.

• Support the management team and clinical team with corporate and programme specific risk management plans, risk based monitoring plans and training.

Essential Experience

• Degree in science, life science, a health related field or quality management.

• A minimum of 7 years in pharmaceutical, biotechnology or CRO environments, ideally spanning clinical research operations and quality assurance.

• Demonstrable GMP quality assurance experience, as time spent working within a GMP suite alone will not meet the requirement.

• Experience managing a quality management system in a quality assurance capacity, reviewing procedures and policies, constructively challenging process owners and identifying gaps against current guidance.

• Detailed knowledge of ICH GCP and GMP, with working knowledge of EU directives and regulations, UK legislation, EU GMP and US FDA cGMP.

• Proven experience managing the interface between quality and regulatory affairs, particularly the regulatory impact of manufacturing changes and clinical trial amendments.

• Strong analytical and decision making capability, with a pragmatic and process oriented approach and credibility across senior stakeholders.

• Willingness to travel.

Desirable Experience

• First hand experience of regulatory inspections.

• Experience with electronic quality management systems.

• Experience conducting GMP audits and working in cleanroom environments.