Associate Director External Quality Assurance
Job Type: Permanent
This is an exciting opportunity to join a global leader in biopharmaceuticals and lead a tech transfer from our clients 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.
- 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.
- Direct experience with managing external partners (CMOs, Labs, etc.)
- Experience with working with new product introductions / product transfers.
- Experience in batch disposition, deviation management, change control and participating in regulatory inspections.
- Moderate level of contractual and financial awareness.
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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