Quality Systems Manager
| Job Type | Permanent |
| Location | Sligo |
| Area | Sligo, Ireland |
| Sector | Quality |
| Salary | Competitive Salary, Bonus + Benefits Package |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3403 |
| Job Views | 124 |
- Description
Team Horizon is seeking a Quality Systems Manager for our Clients Biologics manufacturing facility in the Northwest.
Why you should apply:
- This role will be responsible for a team and to coordinate the development and maintenance of the company’s quality system in compliance with all applicable regulatory requirements and to ensure that products manufactured meet requirements of GMP, end users, Regulatory Authorities and the company.
- Be part of a company who strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care
What you will be doing:
- The Quality Systems Manager is responsible for developing and managing a Quality System, ensuring compliance by all departments and personnel with all applicable Regulatory Authorities and company requirements
- Site SME on Quality Systems issues and provides guidance on same.
- Contributes to the successful delivery of site CJR’s and Goals.
- Leads the delivery of new Quality Systems initiatives.
- Provide technical leadership to functional areas and collaborates with key stakeholders.
- Promotes department goals by selecting, motivating, and training capable staff.
- Contributes to Talent Management of teams within the organisation and to the development of the team to meet evolving business needs
- Preparation and maintenance of Site Master File, Quality Manual and Quality Plans.
- Ensuring that products manufactured meet requirements of end users, Regulatory Authorities and of the company.
- Developing and maintaining performance measurements of the quality system and reporting on this at the management review meeting and during quality performance meetings.
- Liaising with Quality and Compliance Group, FDA, HPRA and other Regulatory bodies
- Act as Designee for Biologics Quality Director as required.
What you need to apply:
- Third Level Qualification in Science, Quality or Engineering to Degree Level (Masters Preferable)
- Minimum of 8 Year’s Experience in the healthcare/pharmaceutical/biopharmaceutical industry
- Minimum of 3 Years Supervisory/People Management experience
- Demonstrated audit/inspection management experience
- Deep knowledge of GMP Requirements and Regulations.
- Ability to make Quality decisions and to run the business while keeping patient focus and safeguarding the company’s reputation.
