Associate Director Quality Assurance, Drug Substance

2 days ago

Louth Village, 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, c GMP, 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 c GMP PPQ Tech Transfer Benefits: Performance Bonus Pension Fund defined benefit pension Company Shares

  • Qa Lead Drug Substance Manufacturing

    2 days ago

    Louth Village, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.The...

  • Senior Process Engineering And Cleaning Validation Engineer

    2 days ago

    Louth Village, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.The...

  • Senior Project Manager

    2 weeks ago

    Louth Village, Ireland beBeeProject Full time €80,000 - €110,000

    We are seeking an experienced professional to manage our projects in a leading biopharmaceutical organization. This is an exciting opportunity for individuals looking to work with a multinational company at the forefront of their industry.Key ResponsibilitiesPlan and execute complex technical transfer projects, including drug substance and product...

  • Senior Biopharmaceutical Project Lead

    4 days ago

    Louth Village, Ireland beBeeBiopharmaceutical Full time €80,000 - €100,000

    A captivating opportunity awaits as a seasoned Project Manager in the biopharmaceutical sector. This exciting role is perfect for individuals eager to make a meaningful impact in a dynamic and fast-paced environment.Key Responsibilities:Develop and execute multifaceted Tech Transfer projects, creating project controls and schedulesLead cross-functional teams...

  • Bioprocessing Shift Lead

    2 days ago

    Louth Village, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.The...

  • Ais Applications Lead

    2 days ago

    Louth Village, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.The...

  • Business Systems Director

    20 hours ago

    Louth, Ireland Scientificjobs Full time

    Business Systems DirectorOur client, a global biologics organisation are currently recruiting for a Business Systems Director to join their team on a permanent basis. As Business Systems Director you will be responsible for promoting and facilitating the successful implementation of the Business System on site. Responsibilities: Accelerate results in SQDIC...

  • Person In Charge

    3 weeks ago

    Louth Village, Ireland Ddean Dchas Eireann Teoranta Full time

    Foscadh g specialises in providing residential support to separated children seeking international protection.Our objective is to provide comprehensive social care supports and accommodation to young people seeking international protection to facilitate their integration and well-being within the community.Overview The role of the PIC ensures the provision...

  • Care Manager

    2 weeks ago

    Louth Village, Ireland beBeeLeadership Full time €54,000 - €63,000

    Job Title: Person In Charge"> ">Job Description:">">The role of the PIC ensures the provision of high-quality, safe, supportive, effective person-centered care to all children within the service.">This is a Monday-to-Friday role, 9am-5pm with an on-call flexibility required.">The PIC is responsible for overseeing the day-to-day operations of a residential...

  • Clinical Nurse Manager 2 Bed Management 2119Cmn2Bm

    1 week ago

    Louth Village, Ireland Hse Workplace Health & Wellbeing Full time

    OverviewThe post of CMM 2 has a pivotal role in service planning, co-ordinating, and managing activity and resources within the clinical area.The main responsibilities are quality assurance, resource management, staffing and staff development, practice development, facilitating communication and professional / clinical leadership.ResponsibilitiesQuality...