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


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

Please contact for more information.

First Name


Your Email (required)

Your mobile (required)

Where did you hear about us?

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

5 Brilliant Benefits of Temping!

Benefits of Temping
  Accepting temporary contracts can be an excellent way of earning an income. Whether you are on holidays from college or ‘in between jobs’, there are plenty of benefits to temping:   CV Regardless of how long a contract is, all jobs bring new and fresh experiences to your CV. Temping is a great way to […]
Read More

Biopharma Report

biopharma biopharmaceuticals industry report
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More
  • Find a job
  • Apply
  • Get a job