Associate Director of Quality, Combination Products
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| Job Type | Permanent |
| Area | Mayo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1002669 |
| Job Views | 469 |
- Description
- Team Horizon is seeking a Associate Director of Quality, Combination Products for our client in Mayo. In this role you will be responsible for ensuring that the device component of all Commercial products manufactured in Mayo are manufactured in compliance with the applicable GMPs and Regulatory Filings and that the relevant business units are adequately controlled and supported to achieve this objective. In this exciting role you will ensure that Combination products manufactured meet the requirements of Regulatory Authorities for those markets where product is distributed and the Quality Management System
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Lead, coach and mentor a QA team responsible for the Implants business to ensure the adherence to GMPs in Implants and drive shop floor compliance
Support Implants Operations through total integration of Quality with the business processes of the BU.
Key advisor to the Core 1 BU as regards the device aspects of new Bio-Tox products.
Responsible for Implants batch record review and QP release process in accordance to regulatory authority and requirements.
Represent Site on Devices/ Combination Products COE as appropriate and develop strong links with MDC and Device Product QA.
Participate in TRIAGE process related to Implants complaints/ product defects. Ability to prepare materials and present above Site.
Ensure timely escalation of quality issues, including complaints to management team and ensure appropriate investigation and corrective/preventive action is undertaken where required.
Ensuring compliance review on change requests are performed on combination products related changes not limited to manufacturing, equipment/technology, processes and procedures.
Responsible for Annual Product Quality Review (APR/ PQR) for Implants products.
Ensuring compliance with the operational quality requirements of applicable regulations that pertain to the Manufacturing of Combination products. Requirements include but not limited to EU MDR, ICH Q8, Q9, Q10, Q11, Q12; PIC/S Guidance; applicable concepts of 21CFR 210 & 211; European Commission, Good Manufacturing Practices for Medicinal Products. Part I and Relevant Annexes; European Commission, Good Manufacturing Practices, Volume 4, Medicinal Products for Human and Veterinary use; Global Quality Assurance Policies.
Mastery of product filings and design history files. Keeps Device knowledge up to date.
Key team member in NPI activity
Drive the principles of RFT and Simplification across standard work. Key support to Implants related FMEAs
What you need to apply:
Third level qualification in a life science or engineering discipline.
Qualified Person status or QP eligibility is an advantage for this role.
At least 7 years industrial GMP experience and 3-5 years supervisory experience. This experience does not have to be limited to Quality Assurance.
Previous experience of Combination or Device products is highly desirable
Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership in a technical environment
Experienced and knowledgeable in EU and FDA cGMPs
Experienced in interacting with regulatory authority inspectors
Experience in managing by metrics
Experienced in aligning individuals and teams to business objectives
Exposure to Lean manufacturing concepts
