Are you passionate about upholding the highest standards of quality and regulatory compliance? Our company is seeking a dedicated and experienced Quality System Lead to join our team at the Dundalk facility. In this key management position, you will play a crucial role in ensuring our Quality Systems and Compliance team objectives are met. If you thrive in a dynamic environment and are committed to excellence, we invite you to apply and be part of our mission to deliver innovative health solutions.
Your Core Responsibilities
- Support the implementation of and maintenance of Global IT Quality Systems and ensure compliance with QMS requirements and procedures.
- Support the operation of the documentation management system that aligns with regulatory requirements.
- Lead delivery of new Quality System initiatives
- As required, ensure an effective change management system is in place to assess the impact of changes on products and processes.
- Coordinate QA related activities and participate in global forums as required
- Provide quality support, training, and guidance on company guidelines and regulatory requirements for Quality System/s
- Represent the site’s Quality System during GMP inspections and FDA PAI readiness activities
- Act as delegate for Site QA Lead as required
Who You Are
You are ready if you have:
- Bachelor's degree in Science, Quality, Engineering, or a related field.
- Minimum of 10 years of experience in Quality Assurance/Compliance, including at least 5 years in a people management role.
- Excellent knowledge of cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, and Training.
- Proven track record in people management within pharmaceutical or biotechnology organizations.
- Experience in the rollout and implementation of quality systems.
- Demonstrated audit/ inspection support experience
Nice to have, but not essential:
- Previous experience in a start-up facility or an acquisition process would be highly advantageous.
