Science & Pharmaceutical JobsQuality Systems Project Manager

  • GY49786
  • Permanent
  • Galway

Collins McNicholas

Role Overview

Quality System Project Manager (will be reporting into Global Quality Systems Director)

This position is responsible for planning, directing and coordinating computerized systems projects within in the Quality & Regulatory function. It includes the successful delivery of projects for the quality and regulatory function, focused on business planning and deployment activities.

This job function has accountability for complying with the applicable elements of the Division Quality System and the associated procedures.

The Project Manager will champion the Quality & Regulatory function, ensure that the business requests are met, and the Quality & Regulatory Processes are followed. This role will interact with the Quality & Regulatory Division & Business Unit leaders, shared services leads and IT leaders.

The candidate will be involved throughout the project lifecycle and will be accountable for the business delivery of the project, representing the Quality & Regulatory function, ensuring an achievable and successful outcome.

Key Duties

  • Carries out duties in compliance with established business policies and procedures.
  • Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO 13485, FDA 21CFR820, and other regulatory agencies.
  • Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
  • Perform other duties and projects as assigned.
  • Lead and manage Quality and Regulatory projects in partnership with Division Quality and IT leadership expectations and priorities.
  • Work directly with the Program leaders to identify, plan and implement the project scope, ensuring the business project risks, issues, and dependencies are understood, communicated and baselined, and ensuring any assumptions are verified.
  • Represent the Quality & Regulatory program and take an active part in steering groups to ensure that project oversight and governance is in place and effective.

Essential Requirements

  • Candidate must come from Diagnostics, Pharma or Med Device industries and have strong IT experience.
  • Fluent business English speaker
  • Bachelor’s Degree or equivalent qualification (as a minimum)
  • Experience (i.e. greater than 3 end-to-end projects) of successfully managing Quality, Regulatory projects, with demonstrable evidence of effective design, delivery and problem-solving skills
  • Project team management experience leading a team greater than 3 FTEs, with a mix of internal and contractor team members, spread across multiple time zones
  • IT projects experience as a business project manager
  • PMP Certification or equivalent (desirable)
  • Supplier qualification and management experience

Package

  • Salary DOE
  • Pension Scheme
  • Healthcare
  • Generous annual leave allowance

Please contact elaine.dolan@collinsmcnicholas.ie for more information.

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