Senior Regulatory Compliance Manager
Salary: €90000.00 - €100000 per annum
Our client is a multinational pharmaceutical organisation. They have an exciting opportunity for a quality assurance professional to join a start up unit based in Dublin West. The incumbent will take ownership of managing the Quality Assurance Progam to ensure compliance with regulatory requirements and minimize any business interruption.
- Communicate all identified compliance and quality risks to supervisor
- Develop departmental policies/procedures to ensure applicable regulatory and corporate quality and compliance requirements are adhered to
- Manage direct reports to assure that quality assurance responsibilities of applicable regulations are fulfilled
- Ensure QA and operations staff receive appropriate regulatory training and mentoring
- Schedule resources to manage compliance systems
- Review and endorse QA reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies
- Liaise with operations to explain audit findings, resolve conflicts, and consult on corrective and preventative actions
- Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements
- Represent the corporation during regulatory and client inspections/audits, prepare site/operation personnel for client inspections/audits, prepare appropriate summaries, coordinate preparation of audit responses and track implementation status
- Responsible for people management including training, promotions, hiring, transfers, scheduling and regular performance feedback
- Bachelor’s degree (B.A. / B.S.) or equivalent
- 5-7 years’ experience either in pharmaceutical and / or biotechnology industry
- Experience in supervision quality assurance, quality control, and / or regulatory affairs
- Prior experience with assisting or managing QA audits and inspections as well as liaising with regulatory agenciesQualified accountant
- Good working knowledge of pertinent regulations and site SOP’s
How to Apply
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For an initial conversation along with a detailed brief of the above position please contact our Recruitment Director, Ross Wynne on 01 531 2424 or click apply below.