Role: Senior GMP QA Specialist
Company Name: Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Contract length: 12 months
Location: Remote (Ireland)
Department: Operational Area Quality
This position reports directly to: Associate Director, Qualified Person,

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.

Senior Quality Specialist role supports the Qualified Persons Team in the principles and application of quality management system and compliance. This role supports QP team in activities relating to QP certification for all commercial and clinical (IMP) programs. 

The role is responsible for the review and compilation of batch files to support QP certification and to support implementation of the QP strategy within the organisation.


Key Responsibilities:

• Provide support on QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
• Liaise with relevant stakeholders to ensure investigation and root cause analysis is completed as per Vertex procedures. Track completion and closure in a timely manner.
• Prepare batch record and batch documentation associated with QP certification and conduct preliminary review for QP approval.
• Veeva actions and related follow ups to close actions on time.
• Support QP team with SOP processing through Veeva.
• Support continuous improvement projects and activities within the Qualified Persons Team.
• Organise payment and any other administrative activities relating to the maintenance of licences held by Vertex Europe (Pharmaceuticals) Ltd.
• 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 GMP QMRs, inspections, ad hoc data requests and other governance meetings.
• Support creation of, and update to, Quality Agreements with Vertex Affiliates and/or QP-to-QP Agreements 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.
• Manage and file quality records according to Vertex records retention policy and procedures.
• Maintenance, and update as required, of the Vertex Site Master File.
• Support internal audit or external audit programs and inspection readiness activities as well as tracking post-inspection readiness.
• Support inspection-readiness activities in conjunction with QP team and IR.
• Support the Qualified Person in the fulfilment of responsibilities associated with the MIA/MIA IMP license.
• Support with post-QP certification activities, including shipment disposition on Vertex inventory management systems and batch record circulation to stakeholders.

• At least 3-5 years operational GMP experience.
• Bachelors degree in a scientific or allied health field 
• Good knowledge of GMP regulations,  
• Good understanding of ICH Q9 and the ability to apply understand the balance between compliance
• and business requirements, and contribute to the development of efficient solutions. 
• Ability to identify and raise risk.  Understand the impact of risk to QA and the business and support mitigation/resolution. 
• Ability to collaborate cross functionally with good communication skills and the ability to influence others by leveraging active listening, and deliver articulate and convincing ideas.  
• Ability to align and adjust activities within ones scope of ownership to positively embrace change and support business growth and process improvements. 
• Demonstrates ability ask questions to clearly under stand requirements. 
• Ability to leverage critical and strategic thinking to determine and mitigate complex challenges and impact. 
• Understand the basic principles of business acumen and how it impacts Quality