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Quality Director

Job Seekers Ireland Science Pharmaceutical

Job Summary

  • Dublin
  • Permanent
  • BBBH764127
  • Aug 05, 2020
  • Competitive
Job Description

A Quality Director is required for a GMP facility in North Dublin.

The Quality Director reports into the Senior Director of Quality. This role is responsible for the wider Quality team with the QC and QA manager reporting into the successful candidate.

 

The Quality Director is responsible for Quality Operations including

  • Auditing of production operations for compliance with Good Manufacturing Practices,
  • Maintenance and approval of validation system documentation,
  • Maintenance of Quality Systems within the plant
  • The Quality Director is also responsible for coordinating site regulatory agency inspections.

The role provides guidance and direction to Quality staff ensuring compliance with all applicable laws, regulations, GMP, and internal Company policies.

 

Detailed Responsibilities:

  • Provide leadership and direction for all Quality activities regarding plant operation and budget goals.
  • Lead the Quality Team to accomplish long term business objectives and prepare for future growth.
  • Allocate and schedule Quality team resources to meet production requirements and maximise productivity.
  • Plan and implement department budget.
  • Accountable for Quality team performance metrics that support the annual operating plan and production objectives.
  • Ensure all Quality reports are current, accurate, and distributed according to defined procedures.
  • Ensure continual improvement of all Quality related documentation (SOPs and On the Job aids).
  • Drives continuous process improvement and Operational Excellence Culture.
  • Provide quality and regulatory guidance to Senior Leadership Team.
  • Ensure Plant compliance with HPRA, FDA and other country regulations as appropriate.
  • Prepare and submit capital projects.
  • Develop a culture of constant site readiness for site inspections.
  • Develop a support / service mentality in Quality staff, partnering with local site departments.
  • Primary point of contact for site regulatory, compliance and quality issues.
  • Identify industry trends and implementation strategies to keep facility ahead of compliance curve
  • Member of the Site Leadership Team.

 

 

The Person:

  • Extensive relevant Quality Management experience. This experience is not limited to Quality Assurance.
  • Strong understanding of manufacturing operations.
  • Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership for all activities across the site QA operations.
  • Experienced in aligning individuals and teams to business objectives.
  • Experience in managing by metrics.
  • Good understanding of EU GMP, FDA regulations as well as Medical device and Cosmetic requirements.
  • Experience managing regulatory inspections.
  • Strong critical thinking, relationship building and leadership skills.
  • Working knowledge of manufacturing practices such as Lean, Six Sigma, Theory of Constraints, and System for Management.
  • Experienced in successfully executing cross functional projects.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

Consultant Details

Consultant Details

Aoife Duggan
Aoife Duggan
  • Senior Consultant
  • +353 21 2300300
  • aduggan@morganmckinley.com