Senior Manager QA- Good Clinical Practic

CPL

DUBLIN CITY CENTRE

My Client is a dynamic biopharmaceutical company that is making a real difference to our patients’ life who suffer from rare diseases. My Client successfully markets rare disorder products and has a robust pipeline of transformative medicines, including gene therapies for diseases of the central nervous system. My Client is looking for a Senior Manager, Quality Assurance - GxP (GCP. The Senior Manager, Quality Assurance - GxP is responsible for executing Quality Assurance (QA) with an emphasis on the Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) auditing and compliance for both clinical and marketed products. This involves engaging and collaborating with cross functional internal teams to evaluate processes, procedures and activities for adherence to relevant industry standards, regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate. The incumbent works cross-functionally with internal departments and external resources on GxP QA related issues. Responsibilities of the role include: Contributes to the execution of the company's GxP audit strategy to achieve compliance with applicable clinical and pharmacovigilance regulations, guidelines and current regulatory requirements. Performs internal and external audits as assigned to assure compliance with GCP and GVP regulations and guidelines (may include internal processes, CROs, investigator sites, AE case processing, and other vendors. Schedules, plans and conducts audits in accordance with audit plan. Communicates audit results to internal stakeholders and writes audit report. Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs. Assists with GXP inspection readiness activities for regulatory authority inspections and coordinates tracking of document requests, responses and supporting documentation during inspections. Contributes to the company's understanding of worldwide regulations, guidelines and GxP practices and assists in helping to meet regulatory compliance and corporate business requirements. This includes, but may not be limited to, the following activities: Maintains working knowledge of current FDA, EU and other global regulation and guidance governing Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) activities. Applies global regulation, agency guidelines and internal procedures to assure compliance. Provides day-to day regulatory compliance guidance support for the Pharmacovigilance department. Represents QA functions on clinical study teams to ensure GCP compliance. Supports Quality Management System (QMS) including, but may not be limited to, the following activities: Contributes to QA review of Pharmacovigilance and Clinical documentation such as PSMF, protocols, CSRs, and regulatory submissions. Drafts and reviews GCP and GVP compliance related SOPs. Assists in identifying and communicating clinical trial-related risks and opportunities for process improvement. Tracks CAPA implementations. Requirements for the role include: Bachelors degree in a scientific discipline and a minimum 5 years of relevant experience in Quality Assurance or Compliance related role in a pharmaceutical or biotechnology environment. Demonstrated knowledge and understanding of GCP regulations. Experience conducting audits. Knowledge and experience in GLP and/or GVP. Registered GxP Quality Assurance Certifications. Experience supporting regulatory agency (e.g., EMA, HPRA, MHRA,FDA) inspections. Up to 30% Travel involved.

1553 days ago