Manager, Market Quality UK

ZipRecruiter; London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global biotechnology company is seeking a Manager for Market Quality in the UK. This role involves overseeing quality assurance activities, supporting compliance, and managing quality systems for medicinal products. The ideal candidate will have expertise in quality assurance, compliance, and experience with GDP/GMP operations. You'll work closely with various stakeholders to ensure the highest standards of quality are maintained.

Qualifications

• Expert in quality assurance and compliance principles.
• Experience with GDP/GMP activities and quality management systems.

Responsibilities

• Support the Responsible Person for license duties.
• Manage deviations and complaints in Veeva QMS.
• Prepare QMS data reports and assist in audits.

Skills

Quality Assurance

Compliance

Root Cause Analysis

Risk Assessment

Tools

Veeva

DocuSign

Job description

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 & finished medicinal products intended for the UK and export markets. The position is recognized as an internal expert in the principles and application of quality assurance and compliance. This role supports GDP operations in the UK, export markets, and management of 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 duties associated with the license.
2. Act as backup Responsible Person in the absence of the primary Responsible Person and as named on the WDA.
3. Support self-inspections, internal audits, and Health Authority inspections through preparation, performance, and closure of deficiencies where applicable.
4. Take ownership and support QMS processes (Deviations, CAPA, & Change Controls), including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
5. Manage the International Quality inbox (intake, triage, and timely responses to QA queries).
6. Support the intake, triage, and logging of deviations & complaints into the Veeva electronic Quality Management System (VeeQMS).
7. Liaise with relevant stakeholders to obtain full information to initiate investigations and root cause analysis as per Vertex procedures. Track completion and closure promptly.
8. Prepare materials for 3PL sites to monitor deviation performance, cascade information, and follow up on outstanding items.
9. Support GDP operational quality by gathering relevant documentation for disposition on temperature excursions.
10. Raise risks/issues with timelines and seek support for timely resolution.
11. Support change control records as required and complete assigned quality actions.
12. Prepare relevant QMS data reports/KPIs on Deviations, CAPA, Change Controls, and Effectiveness checks for Affiliate QMRs, inspections, ad hoc data requests, and governance meetings.
13. Assist in creating and updating Quality Agreements with Vertex Affiliates and external vendors by drafting using global templates, collecting review comments, obtaining approval signatures via DocuSign, and uploading to the VeeDMS system.
14. File quality records according to Vertex records retention policies and procedures.

Vertex is partnering with Talent Works to manage their international temporary job openings. If successful, you will be employed by Talent Works to work on a temporary assignment at Vertex.