23579-Quality Specialist – Dublin Contractor

This is a 6-month contract. Fully remote.

Purpose

The Senior Specialist – External Quality Vaccines acts as Product Quality Manager (PQM), responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements. The role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners (EP/ExP’s) manufacture and release of vaccine drug substance and drug products by means of risk-based quality oversight and on-site supervision, as appropriate.

Responsibilities

• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations
• Review and approve change controls
• Manage routine and complex deviations and complaints and assist in the coordination of significant investigations
• Conduct routine and solve complex analytical change requests and support process modification change controls
• Stability Program management, including review of stability reports, and Annual Product Review assembly
• Provide on-site guidance in the preparation of metrics, procedures, and guidelines
• Track and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plans
• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration
• Responsible for shipment under quarantine

Support routine process validation; review and approve validation reports/tech transfer

• Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes

Qualifications

• Educational background in a relevant discipline
• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
• Solves complex problems; takes a new perspective using existing solutions
• Works independently with minimal guidance
• Acts as a resource for colleagues with less experience within own discipline; can provide guidance on issue resolution and act as SME
• Explains difficult issues and works to build alignment around a complex situation
• Accountable for a medium project with minimal resource requirements, risk and/or complexity
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
• Communicates easily in English both verbally and in writing
• Strong knowledge of External Manufacturing management, supply chain, and operations, preferably direct experience with managing external partners
• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience
• Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs)
• Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ)
• Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards
• Quality Risk Management (QRM) Experience