AD of Operational Compliance

  • Cork
  • Permanent
  • JO-1709-62830_1510742817

Summary

Responsibilities

  • Interprets internal and external regulatory and compliance developments and communicates action to Department and site as appropriate.
  • Is the front room lead in the Department for all corporate and external body audits
  • Act as coach for all members of department in compliance.
  • To embed a culture of compliance and safety excellence within the Biologics team, and to work with compliance peers across the business to ensure best practice compliance is implemented.
  • Accountable for development and deployment of visual metrics within the Department.
  • Develops innovative lean compliance systems that anticipate future department needs aligned with industry best practice
  • Engages with senior stakeholders (internal & external) to influence outcomes as appropriate.
  • Core team member at site Quality and EHS Councils.
  • Accountable for PIR in the department, including development and maintenance of a proactive compliance risk register for the Department to ensure PIR.
  • Accountable for all maintenance & adherence to standards owned within the department e.g. QMS, Engineering Standards, Validation Standards.
  • Responsible for proactive monitoring of CAPAs to ensure holistic trends are proactively resolved
  • Responsible for overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA
  • Create collaboration links across site SLT to share best practices.
  • Ensures compliance is at the core in development of departmental strategies.
  • Departmental Tier 4 owner for Compliance
  • Ensure the highest Quality, Compliance and Safety standards.
  • Participate and comply with the MMD Quality Management System (QMS) requirements, including ownership, as relevant.
  • Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT.
  • The Associate Director of Operational Compliance who is recognized as the Compliance expert within the Department will provide strategic and operational leadership to manufacture and supply quality pharmaceutical products

Requirements

  • >10 years' experience in pharmaceutical industry.
  • >5 years' experience in operational leadership.
  • Demonstrated technical knowledge and experience in compliance
  • Degree in (Science/Engineering)
  • Green Belt or suitable alternative in MPS
  • Demonstrated use of the Leadership Behaviours
  • Evidence of Continuous Professional Development
  • Demonstrated self-motivation/direction skills with a continuous improvement focus.
  • Demonstrated technical capability in EHS.
  • Demonstrated ability to lead and realise improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
  • Advanced PC skills such as Excel, Word, PowerPoint.

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