Manager, Market Quality UK (London)

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 the GDP/GMP activities performed by Vertex Pharmaceuticals (Europe) Limited for active substances & finished medicinal products intended for the UK and export markets. Position is recognised as an expert internally 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 & Commercial.

Key Responsibilities:

• Support the primary Responsible Person in the fulfilment of duties associated with the license.
• Act as backup Responsible Person in the absence of the primary Responsible Person and named on the WDA to act in this capacity.
• Support Self-Inspections, internal audits and Health Authority inspections via preparation, performance, and closure of deficiencies identified where applicable.
• Take ownership and provide support on QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
• Management of International Quality inbox (intake, triage, and timely responses to QA queries).
• Support the intake, triage, and logging of deviations & distribution complaints into the Veeva electronic Quality Management System (VeeQMS).
• Liaise with relevant stakeholders to obtain full information to initiate investigation and root cause analysis as per Vertex procedures. Track completion and closure in a timely manner.
• Prepare materials for 3PL sites to monitor performance on deviations, cascade information and follow up on outstanding items.
• Support GDP operational quality in gathering relevant documentation for disposition on temperature excursions.
• Raise risks/issues with timelines and seek support in timely resolution.
• Support change control records as required and complete any quality actions assigned.
• Prepare relevant QMS data reports/KPIs on Deviations, CAPA, Change Controls and Effectiveness checks, for Affiliate QMRs, inspections, ad hoc data requests and other governance meetings.
• Support creation of, and update to, Quality Agreements with Vertex Affiliates and external vendors by; drafting using global templates, collation and amendment based on review comments, collection of approval signatures via DocuSign & upload to the VeeDMS system.
• File quality records according to Vertex records retention policy and procedures.

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