Quality Compliance Manager | Collins McNicholas

Quality Compliance Manager

  • Reference: 42339
  • Job Type: Permanent
  • Location: Dublin City Centre, Dublin North, Dublin West
  • Category: Science, Pharmaceutical & Food

JOB TITLE:               QA Compliance Manager 


We are seeking a experience QA Manager  to work as part of a global compliance Team.  Your primary objectives will be to ensure all manufacturing and TPM’s sites meet compliance regulations .   You will also be responsible for leading continuous improvement initiatives, global quality projects, compliance initiatives, and risk assessments and remediation activities involving various areas under your regions. 

Key Responsibilities:

  • Provides inspection readiness support to the sites -identification of compliance gaps and risks, and participation in the remediation process.
  • Provide on-site support during regulatory inspection, as applicable.
  • As part of the Global Compliance team, supports the Pharmaceutical Compliance Excellence Program during coordination and execution of on-site assessments and the identification of remediation plans.       
  • Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close.
  • Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis.
  • Responsible for communication and documentation of internal and external compliance related information. 
  • Responsible for leading continuous improvement initiatives including creation, scoping and implementation.
  • Manages assigned global quality projects and compliance initiatives.
  • Trains employees on areas of expertise, as requested
  • Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
  • Represents the sites one  Corporate wide initiatives and teams as requested

 Your Background:

  • 7-10 year’s experience in pharmaceutical Industry or government regulatory agency and at least 5 years of GxP experience with responsibility for managing the quality system
  • Experience in conducting and handling audits and inspections
  • Strong knowledge of relevant regulations for quality systems and compliance.
  • General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology
  • Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
  • Capable of analysing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
  • Excellent verbal and written communication skills, and project management skills.
  • Bachelor Degree in a  relevant scientific/ technical discipline such as Chemistry, Pharmacy, Engineering, Biology, Microbiology,
  • Travel will be required.

    For a confidential discussion and more information on the role, please contact Mary Mullin  on 09064 78104 or email mary.mullin@collinsmcnicholas.ie

    For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Contact Consultant

  • Mary Mullin
  • Regional Manager
  • 09064 50661
  • Connect with Mary

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