Description:
This is an exciting opportunity to join a global leader in biopharmaceuticals and lead a tech transfer from our client’s site into a startup contract manufacturer in Louth. The AD External Quality Assurance will be an individual contributor so people management experience is not required. The ideal candidate will have experience in tech transfer and have a background in Biologics, Vaccines or sterile manufacturing.
Key Responsibilities
- Serve as the quality project lead for Technology Transfer, New Product Introduction and Analytical Transfers to Contract Manufacturing and testing sites (start-up facility).
- Assist in managing the end-to-end processes of transfers including but not limited to Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness and Quality System Oversight Implementation.
- Accountable for oversight of an External Entity (EE) involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
- Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight | Components may include review of batch documentation and deviation investigations.
- Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews | Includes building effective quality systems at the EE and continuous improvement activities.
- Exhibits our company Leadership Behaviours and provides a leadership example for the team.
- Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
- Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
- Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
What our Client can Offer you:
- A unique opportunity to join a global leader and lead a tech transfer into a start up facility where you will experience a startup environment, with the security of being employed by an established leading Pharmaceutical company.
- Join a newly established team, developing an excellent culture, work on life saving products that have a global impact.
- Guaranteed Career development opportunities!
- Highly competitive salary & benefits package.
What you will need to succeed:
- Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience.
- Strong and principled interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
- Works independently, receives minimal guidance.
- Communicates in English both verbally and in writing.
- Local to the area, who will provide at least 3 days / week on-site support in the Louth area (Ireland), remainder at home.