Reference Number: JO-2003-448071
Senior Manager, Quality Assurance – GXP
Job Type: Permanent
Location: County Dublin
SENIOR MANAGER, QUALITY ASSURANCE GXP
Location: Dublin, Ireland
Salary: Excellent/Dependent on experience and full bonus/benefits package including share options + relocation assistance (if required)
Our client, an exciting, established global biopharmaceutical company undertaking a period of extensive growth, is currently looking to recruit for a senior pharmaceutical/Biotech Quality Assurance Specialist for a highly visible and responsible role, ensuring compliance for both clinical and marketed product lines. Working across all internal teams, the focus will primarily be on GCP and GVP Audit and compliance processes, therefore significant experience in these practices is essential.
As the Senior Manager, Quality Assurance GXP, responsibilities will include (but not be limited to):
Contributing to the execution of the company GxP audit strategy to achieve compliance with applicable clinical and pharmacovigilance regulations, guidelines and current regulatory requirements.
Performing internal and external audits as assigned to assure compliance with GCP and GVP regulations and guidelines (may include internal processes, CROs, investigator sites and other vendors)
o Scheduling, planning and conducting audits in accordance with audit plan.
o Communicating audit results to internal stakeholders and writes audit report.
o Assessing audit responses and ensures closure of corrective action preventative actions (CAPAs).
Assisting with GXP inspection readiness activities for regulatory authority inspections and coordinates tracking of document requests, responses and supporting documentation during inspections.
Contributing to the company understanding of worldwide regulations, guidelines and GxP practices and helping to meet regulatory compliance and corporate business requirements. This includes, but may not be limited to, the following activities:
o Maintaining working knowledge of current FDA, EU and other global regulation and guidance governing Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) activities.
o Applying global regulation, agency guidelines and internal procedures to assure compliance.
o Providing day-to day regulatory compliance guidance support for the Pharmacovigilance department.
o Representing QA functions on clinical study teams to ensure GCP compliance.
Supporting Quality Management System (QMS) including, but may not be limited to, the following activities:
o Contributing to QA review of Pharmacovigilance and Clinical documentation such as PSMF, protocols, CSRs, and regulatory submissions.
o Drafting and reviewing GCP and GVP compliance related SOPs.
o Assisting in identifying and communicating clinical trial-related risks and opportunities for process improvement.
o Tracking CAPA implementations.
This role represents an outstanding opportunity for a highly experienced Quality Manager/specialist to build on their existing GCP and GVP Quality Assurance experience and take a fundamentally important role in a growing business.
If you are interested in this opportunity please call Jim Maddison at Scientific Professionals on +44 (0) 207 822 1710 or send an updated version of your CV via email to email@example.com
Not quite the right role for you? We do operate a generous bonus referral scheme should we go on to place anyone that you recommend to us so please feel free to pass these details forward.