Senior Regulatory Compliance Manager

Job Reference: BBBH555

Salary: €90000.00 - €100000 per annum

Salary per: Annum

Job Duration:

Job Start Date:

Job Description

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.

The Role:

  • 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

The Person:

  • 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.

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