Reference Number: JO-1911-441686
Senior Manager, Quality Assurance – GXP
Job Type: Permanent
SENIOR MANAGER, QUALITY ASSURANCE GCP/GXP
Location: Dublin, ROI
Salary: Excellent/Dependent on experience and full bonus/benefits package + Relocation assistance (if required)
Our client, an exciting, global biopharmaceutical company undertaking a period of extensive growth, is currently looking to recruit for a senior pharmaceutical/Biotech Quality Management Manager 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 Audit and compliance Processes.
As the Senior Manager, Quality Assurance GCP/GXP, responsibilities will include (but not be limited to):
Responsibility for the execution of the GxP audit strategy to achieve compliance with relevant clinical and pharmacovigilance regulations, guidelines and current regulatory requirements.
Performing internal and external audits as assigned to assure compliance with GCP and GVP regulations
Scheduling, planning and conducting audits in accordance with audit plan.
Communicating audit results to internal stakeholders and writes audit report.
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 business understanding of worldwide regulations, guidelines and GxP practices and assists in helping to meet regulatory compliance and corporate business requirements.
The successful candidate will possess:
A 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 in 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.
The ability to travel globally for 30% of the role
This role represents an outstanding opportunity for a highly experienced senior Quality Manager to build on their existing GCP 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 firstname.lastname@example.org
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