Associate Director Quality Assurance, Drug Substance

3 weeks ago

Dundalk, Ireland Brightwater Full time

Associate Director Quality Assurance, Drug Substance & Drug Product About the Company Join an innovative biopharmaceutical company at the forefront of vaccine development.
This growing site is building a dynamic team, focused on operational excellence, compliance, and cutting-edge technology in a fast-paced, startup-like the Position We are seeking an experienced Quality Assurance professional to lead the QA Operations team, covering both Drug Substance (DS) and Drug Product (DP) manufacturing.
This pivotal role will ensure GMP compliance across the site, guide a growing team of specialists, and support the site through technology transfer and GMP readiness activities.
The ideal candidate thrives in complex environments, is used to startup or early-stage manufacturing operations, and can combine hands-on expertise with strong leadership.
Key Responsibilities Act as the QA Operations lead for onsite quality monitoring of DS and DP manufacturing.
Support technology transfer, shake down batches, and site GMP readiness initiatives.
Lead and develop a QA Operations team (currently 46 FTEs), fostering accountability and strong performance.
Review, approve, and audit manufacturing documentation to ensure regulatory and company compliance.
Provide QA guidance across manufacturing and cross-functional teams, supporting compliance and continuous improvement initiatives.
Support inspections and self-audits, providing coaching and guidance to the team.
Experience/Requirements Degree in Biopharmaceutical Science or a related discipline.
Minimum 8 years experience in vaccine or biopharma DS/DP manufacturing, with sterile filling experience highly desirable.
Proven track record in managing a team, mentoring specialists, and driving operational excellence.
Experience in startup or early-stage facility environments, including GMP readiness and inspections.
Strong knowledge of European regulations, cGMP, and quality compliance standards.
Excellent interpersonal and communication skills, able to work collaboratively in a matrix environment.
Ability to adapt in a fast-changing environment, balancing compliance with operational demands.
Remuneration Package Competitive salary: up to €110k (with potential sign-on bonus) Annual bonus: 12% of salary (company and personal performance-based) Long-Term Incentives (performance-based, awarded over 3 years) DB and DC pension schemes 25 days annual leave Full-time onsite role (with potential for future hybrid flexibility) Skills: Quality Assurance drug product drug substance vaccines cGMP PPQ Tech Transfer Benefits: Performance Bonus Pension Fund defined benefit pension Company Shares

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