Social network you want to login/join with:
Biotech QA Manager - External Suppliers - Remote, Dublin
Client: JobContax
Location: Dublin, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: d8d21bea0d86
Job Views: 5
Posted: 30.06.2025
Expiry Date: 14.08.2025
Job Description:
Biotech QA Manager - External Suppliers - Remote
Employment Type: Contract
Work Location: Remote
Experience: 10+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international biotechnology company with a state-of-the-art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.
Responsibilities include quality and compliance oversight of contract labs, CMOs, or raw material SREs, and alignment with CTA/Marketing applications.
Be an integral part of a cross-functional contract manufacturing team, including business operations, analytical science, process development, and supply chain XPD.
Negotiate and approve quality agreements.
Lead preparation for and represent the company during product-specific regulatory inspections and audits of CMOs, as needed.
Present during inspections, demonstrating appropriate behavior and knowledge.
Review and approve master batch records, deviations, change controls, and CAPAs.
Prepare inspection playbooks and identify risk at CMOs or testing laboratories, escalating issues as necessary.
Perform Person in Plant activities as required, manage audit commitments, and support batch disposition activities for lot release.
Make decisions regarding batch release or rejection, deviations, change controls, and other quality assessments.
Provide quality input on GMP topics and strategy, approve master batch records and raw material specifications.
Requirements
Doctorate with 2 years related experience, or
Master’s with 4 years, or
Bachelor’s with 6 years, or
10+ years biotech/pharmaceutical experience.
European language skills are desirable but not essential.
Significant quality experience in aseptic manufacturing facilities.
Ability to influence senior stakeholders, manage workload, and utilize project management tools.
Strong project management, problem-solving, and leadership skills.
Experience working in a matrix environment and driving decision-making using DAI principles.
Broad experience in deviation management, regulatory affairs, filings, and GMP compliance.
Autonomous, proactive, and able to hit the ground running.
Willingness to travel within Europe as needed.
Package: Fully remote with quarterly onsite visits in Dun Laoghaire and occasional travel across Europe.
#J-18808-Ljbffr