Manager, Market Quality UK

JR United Kingdom; London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global biotechnology company seeks a Manager for Market Quality in the UK. This role supports GDP/GMP activities, ensuring compliance and quality assurance. The successful candidate will manage quality processes, support inspections, and liaise with stakeholders to ensure operational excellence.

Qualifications

• Internal expert in quality assurance and compliance.
• Experience with GDP/GMP activities.

Responsibilities

• Support the primary Responsible Person in fulfilling license duties.
• Manage QMS processes including Deviations and CAPA.
• Prepare materials for 3PL sites to monitor deviations.

Skills

Quality Assurance

Compliance Principles

Risk Assessment

Tools

Veeva Quality Management System

Job description

Looking for opportunities with purpose, impact, and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

General position summary:

The Manager, Market Quality UK (Contractor) role supports GDP/GMP activities performed by Vertex Pharmaceuticals (Europe) Limited for active substances and finished medicinal products intended for the UK and export markets. The role is recognized as an internal expert in quality assurance and compliance principles and application. This position supports GDP operations in the UK, export markets, and manages events under 3PLs within the UK & EEA territory. Key stakeholders include GMP Operations QA, International Supply Chain, Global Compliance & Systems, Regulatory Affairs, Pharmacovigilance, and Commercial.

Key Responsibilities:

1. Support the primary Responsible Person in fulfilling license duties.
2. Act as backup Responsible Person when the primary is unavailable, as designated on the WDA.
3. Support self-inspections, internal audits, and Health Authority inspections, including preparation, performance, and closure of deficiencies.
4. Manage QMS processes (Deviations, CAPA, Change Controls), including Root Cause Analysis, Risk Assessment, and timely closure of records.
5. Manage the International Quality inbox for QA queries.
6. Support the intake, triage, and logging of deviations and complaints into Veeva Quality Management System (VeeQMS).
7. Liaise with stakeholders to gather information for investigations and root cause analysis, tracking progress and closure.
8. Prepare materials for 3PL sites to monitor deviations, communicate information, and follow up on outstanding items.
9. Support GDP operational quality by gathering documentation for temperature excursion dispositions.
10. Raise risks/issues related to timelines and seek support for resolution.
11. Support change control records and complete quality actions as required.
12. Generate QMS data reports/KPIs on Deviations, CAPA, Change Controls, and Effectiveness checks for governance meetings.
13. Assist in creating and updating Quality Agreements with Vertex Affiliates and external vendors, including drafting, review, approval, and uploading.
14. File quality records according to Vertex records retention policies and procedures.

Vertex partners with Talent Works for managing international temporary job openings. Successful applicants will be employed by Talent Works for a temporary assignment at Vertex.

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Created on 19/05/2025 by JR, United Kingdom