Quality and Compliance Operations Manager
Full Time Permanent
Northern Cross
The QCS Manager will manage the operations of our Quality and Compliance function across the Uniphar MedTech Group.
The primary purpose of the role is to support our quality and compliance team, ensuring the ongoing maintenance of our compliance requirements, driving success by exceeding our contractual and regulatory obligations and internal quality standards. This role oversees the Quality Management System (QMS), drives continuous improvement, and ensures operational compliance across distribution activities.
As QC Operations Manager, you will play a critical role in delivering optimal processes within the function and across the organisation. Reporting directly to the Head of Quality MedTech, you will be a hands-on, approachable manager, leading and mentoring team members to deliver best in class standards within the industry.
You will be highly motivated, with a passion for Quality and will support our continued drive towards excellence in Compliance.
Key responsibilities will include:
- Hands on input and support managing queries across multiple elements of our function.
- Analyse current operational processes within the Quality and Compliance function and drive improvements.
- Work as an enabling function to translate company strategies into deliverable projects.
- Act as a senior level Business Partner with our Commercial, Operational and Finance Teams to ensure alignment towards Group level objectives.
- People management - developing and supporting team members to be their best.
- Have an awareness of and experience in each area (Regulatory Affairs, EUDR European Database on Medical Devices), Quality, Ethics) to be able to support the team with escalation of queries and delivery of objectives.
- Support each team member to reach their potential and deliver agreed objectives across the team reporting monthly, quarterly and annually across multiple business units.
- Be an integral part of building a centre of excellence for Compliance.
- Work with team members to ensure any bottlenecks or areas for improvement can be managed and escalated to you, where required.
- Maintain and improve the QMS in line with ISO 13485 and relevant regulations.
- Monitor compliance in warehousing, distribution, and logistics.
- Conduct risk assessments and implement mitigation strategies.
Our QCS function works as a positive, fun, enabling function to identify best practices and share them group wide. We view QCS as an integral part of how we achieve our commercial goals and the Quality and Compliance Operations Manager will be an essential team member in delivering this programme.
Role Requirements:
The role is a full-time role, based in Dublin, Ireland with a minimum of 3 days per week onsite. Travel to other European sites will be part of the role, in line with the quality and compliance requirements.
The successful candidate will be hard-working and enthusiastic with experience in quality, compliance and regulatory affairs. They should have the following skills and qualifications:
- Fluency in English is essential. Additional European languages would be advantageous.
- Third level qualification required in Quality, Science, or Business or demonstrable work experience at a specialist level.
- Three years’ experience working within Medical Device and/or Pharma distribution within Quality or Regulatory Affairs role
- People management experience is essential.
- ISO 9001:2015 Lead Auditor Certification desired. Experience with additional standards such as ISO 13485 / ISO 14001 / ISO 5001 would be advantageous.
- Experience with a QMS software solution.
- A strong understanding of the MDR Regulations.
- Strong communication, interpersonal and prioritising skills.
- Attention to detail and analytical thinking.
- Good planning & organising skills, good time management.
- Ability to work effectively and co-operatively with others.
- A good work ethic with a positive, can-do attitude and approach to work.
- Ability to work on their own initiative and equally as part of a team.
- Strives for Continuous Improvement.
- Full clean drivers’ licence and own car required for travel between sites.