Senior QA Manager

  • Cork
  • Permanent
  • JO-1701-62112_1499848900

Summary

Senior QA Manager

Responsibilities

  • Recruit, develop and lead the QA team in areas of expertise and high performance team behaviours
  • Provide technical expertise and leadership to the QA group with regard quality systems, document control and lot release
  • During development and start up phases of the facility, plan for and lead, in collaboration with project and support functions, the set up facility and quality systems and procedures
  • Drive implementation of a science and risk based Quality Culture throughout the facility
  • Lead the preparation and facilitation of Regulatory Inspections
  • Oversee activities relation to core quality systems including Deviations, Change Control and CAPA Systems
  • Oversee relevant metrics for each quality system
  • Participate in the Operations daily management meeting and coordinate all related activities including meeting minutes, distribution list, agenda topics, action items, correspondence, scheduling, etc.

Requirements

  • 8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
  • QP qualification would be an advantage.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.

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