Market Quality Senior Manager & Responsible Person, 12-month contract
Vertex Pharmaceuticals (Ireland) Ltd
Type of Role: Contract position
Contract length: 12 months
Location: Hybrid, 3 days on site in Dublin 9
This Position Reports to: Associate Director, 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.

Position Summary:
This role is responsible for maintaining the Vertex Pharmaceuticals (Ireland) Limited quality management system, ensuring it meets the requirements of GMP (Marketing Authorisation Holder Activities) and GDP (Wholesale Distribution Activities and Active Substance Importation/Distribution).

This position involves acting as Deputy Responsible Person, named on the Wholesale Distribution Authorisation (WDA W11309/0001) for Vertex Pharmaceuticals (Ireland) Limited, located at Unit 49, Block 5, Northwood Court, Northwood Crescent, Ireland D09 T665, fulfilling the duties of the RP in the event of their absence or where this is appropriate justification for delegation of activities.

Key Responsibilities:

• Act as Deputy Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA) held by Vertex Pharmaceuticals (Ireland) Ltd, ensuring in partnership with the RP/ DRP, that operations are compliant with HPRA guide to Good Distribution Practice of Medicinal Products for Human Use and EU Guidelines of 5 Nov 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).
• This role has the authority to take decisions with regard to their responsibilities when so delegated by the RP. This includes;
  • ensuring that a quality management system is implemented and maintained.
  • focusing on the management of authorised activities and the accuracy and quality of records.
  • ensuring that initial and continuous training programmes are implemented and maintained.
  • coordinating and promptly performing any recall operations for medicinal products.
  • ensuring that relevant customer complaints are dealt with effectively.
  • ensuring that suppliers and customers are approved.
  • approving any subcontracted activities which may impact on GDP.
  • ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
  • keeping appropriate records of any delegated duties.
  • deciding on the final disposition of returned, rejected, recalled or falsified products.
  • approving any returns to saleable stock.
  • ensuring that any additional requirements imposed on certain products by national law are adhered to.
  • remaining continuously contactable and available to attend the site as required.
  • ensuring the WDA accurately reflects the current organisation, performing variations where necessary.
• Support activities pertaining to the Active Substance Registration as per EU Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for Human Use (2015/C 95/01).
• Performing review and approval of appropriate GxP documentation including procedures, work instructions, records and Quality Agreements.
• Ensuring audits and other qualification activities are performed for all outsourced activities to ensure their compliance to the applicable GxP requirements.
• Supporting management review for Vertex Ireland.
• Participation in quality risk management activities.
• Participation in quality escalation meetings, providing input as an RP for Ireland (when delegated) .
• Maintain oversight of 3PL processes for Deviations, Distribution Complaints, CAPA, Change Control and Returns via:
  • Perform triage of new deviations.
  • Review deviation investigations & CAPA plans provided by 3PL.
  • Assess impact to Vertex from 3PL Change Controls and manage associated actions required by Vertex.
  • Providing input into 3PL documentation.
  • Regular meetings with 3PLs to review return reconciliation, monitor for trends and assess KPIs.
• Supporting Regulatory inspections (Providing front and backroom inspection support and leading post inspection follow-up with responses and CAPAs).
• Monitoring, assessing impact and communicating Regulatory Intelligence information.
• Maintaining knowledge of EU Good Distribution Practice, applicable Good Manufacturing Practice and local GDP/GMP guidance’s.
• Participate in internal audit program and support external audit scheduling, scope, and other qualification activities.

• Bachelor’s degree in a scientific or allied health field and 4-5 years of relevant work experience.
• Eligible to act as a Responsible Person.
• Broad regulatory agency knowledge and experience in GDP/GMP with current knowledge of industry trends and best practices.
• Excellent communication skills.
• Work cross-functionally with all levels to foster exceptional collaboration.
• Root Cause Analysis tools/methodology.
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint).
• Sense of urgency- ability to act quickly/escalation process/transparency.
• Attention to detail

• Degree in pharmacy, chemistry, medicine, biology or a related life science.
• GDP & GMP work experience, or relevant comparable background.
• Experience as Responsible Person/Deputy Responsible Person.
• Experienced Lead Auditor.