About the job

GCP QA Manager / QA LeadNorth West England | Hybrid |

The companyA fast-growing, AI-driven medical imaging business providing core lab services to pharmaceutical and biotech sponsors running clinical trials. Its software reads and analyses trial imaging, and the results feed directly into sponsors' trial endpoints.

The opportunityThis is a new, standalone role and the company's first dedicated GCP quality hire. Until now, quality and regulatory work has centred on the company's software. As the core lab has grown, so has the need for someone who owns GCP across the business.

You'll report directly to the COO, independent of core lab operations, and have full ownership of the GCP quality programme. A GCP gap analysis has just been completed, so you'll start with a clear picture of what needs fixing and the autonomy to decide how. The company is also moving to a dedicated eQMS, and you'll help shape and build it out.

It suits someone working at QA Manager level who wants to build something rather than maintain it. As the business grows, the role is expected to grow into a senior position with regular exposure to the board.

What you'll doBuild and implement the GCP quality framework for core lab services and integrate it into the company's eQMS.
Take ownership of CAPA management, drive open actions to evidenced closure and put a system in place that keeps them there.
Lead the hosting of sponsor audits from preparation to close-out, and act as the main QA contact for sponsor quality teams.
Streamline how the company responds to sponsor vendor qualification requests, so commercial teams aren't left waiting.
Run a risk-based audit and qualification programme for the company's own vendors and service providers.
Own document control and GCP training, and keep the business inspection-ready.
Report quality metrics and trends to senior leadership and advise on the GCP implications of new studies.

What you'll bringAt least five years in clinical research quality assurance within a sponsor, CRO, core lab or clinical trial services provider.
A track record of independently running GCP audits from planning to closure.
Direct experience hosting sponsor audits or regulatory inspections.
Hands-on CAPA experience, including root cause analysis and effectiveness checks.
Experience in a smaller or growing organisation where you've owned quality end to end, not one small part of it.
The confidence to influence a business that is still learning about GCP, and to stand by your findings.

Lead auditor certification, RQA membership or imaging experience would be useful but aren't essential.

PracticalitiesHybrid working, with an on-site presence expected in the early months while you establish the quality programme. Travel within the UK and Europe, and occasionally the US. UK.

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Responsibilities

About the job

GCP QA Manager / QA LeadNorth West England | Hybrid |

What you'll doBuild and implement the GCP quality framework for core lab services and integrate it into the company's eQMS.
Take ownership of CAPA management, drive open actions to evidenced closure and put a system in place that keeps them there.
Lead the hosting of sponsor audits from preparation to close-out, and act as the main QA contact for sponsor quality teams.
Streamline how the company responds to sponsor vendor qualification requests, so commercial teams aren't left waiting.
Run a risk-based audit and qualification programme for the company's own vendors and service providers.
Own document control and GCP training, and keep the business inspection-ready.
Report quality metrics and trends to senior leadership and advise on the GCP implications of new studies.

What you'll bringAt least five years in clinical research quality assurance within a sponsor, CRO, core lab or clinical trial services provider.
A track record of independently running GCP audits from planning to closure.
Direct experience hosting sponsor audits or regulatory inspections.
Hands-on CAPA experience, including root cause analysis and effectiveness checks.
Experience in a smaller or growing organisation where you've owned quality end to end, not one small part of it.
The confidence to influence a business that is still learning about GCP, and to stand by your findings.

Lead auditor certification, RQA membership or imaging experience would be useful but aren't essential.

PracticalitiesHybrid working, with an on-site presence expected in the early months while you establish the quality programme. Travel within the UK and Europe, and occasionally the US. UK.