Role: Quality Specialist
Company Name: Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Contract length: 12 months
Location: Hybrid, 3 days on site in Dublin, Ireland (Unit 49, Block 5, Northwood Court, Northwood Crescent, Northwood, Dublin 9, D09 T665)
Department: Distribution & Market Quality

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 Summary:

• The Quality Specialist role supports Market Quality in the principles and application of quality management system and compliance.
• This role supports market quality for all distribution activities within the affiliate distribution network.
• Key stakeholders include Operations QA, International Supply Chain, Logistics.
• Geographic expansion in particular support to LATAM market quality, QMS QA, Vendor Management and AIM QA.

• Provide support on QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
• 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.
• Veeva actions and related follow ups to close actions on time.
• Support Market Quality with SOP processing through Veeva.
• 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.
• File quality records according to Vertex records retention policy and procedures.
• Support internal audit or external audit programs and inspection readiness activities as well as tracking post-inspection readiness.
• Support GDP operational quality in gathering relevant documentation for disposition on temperature excursions.
• Support self-inspections, preparation, performance, and closure of deficiencies identified.
• Management of international quality inbox (intake, triage, and timely responses to QA queries).
• Support the Responsible Person in the fulfilment of responsibilities associated with the license.

• Bachelor’s degree in a scientific or allied health field.
• General knowledge of International GDP regulations; knowledge of GMP and GVP regulations.
• Good understanding of ICH Q9 and the ability to apply the balance between compliance and business requirements and contribute to the development of efficient solutions.
• Ability to support risk mitigation and escalate risks as appropriate.
• Ability to collaborate cross functionally with good communication skills and the ability to influence others by leveraging active listening and delivering articulate and convincing ideas.
• Ability to demonstrate openness to changes and resilience during times of flux and transformation.
• Demonstrates ability to ask questions to clearly understand requirements.
• Ability to leverage knowledge to identify complex issues and/or risks.
• Understand the basic principles of business acumen and how it impacts Quality.