Head of Sterility Assurance and Microbiology

3 weeks ago


Cork, Cork, Ireland Elusav Recruitment Full time

Elusav Recruitment have an amazing opportunity for a Head of Sterility Assurance and Microbiology with a leading global biopharma company in Waterford, Ireland.

As the Head of Sterility Assurance and Microbiology you will be responsible for developing and implementing effective strategies and procedures for sterility assurance and microbiology across the organization.

Responsibilities:

  • Develop and implement comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives.
  • Ensure the compliance of products and processes with applicable sterility assurance and microbiology regulatory requirements and company quality standards.
  • Maintain a system to ensure sterility assurance and microbiological risks are properly identified, tracked and mitigated.
  • Oversee, with Q&V team, the validation, qualification and monitoring of methods, equipment and the environment ensuring sterility assurance control.
  • Follow metrics and monitor data for the sterility assurance and microbiological activities, to identify trends and issues and to implement action plan.
  • Promote a culture of quality throughout the organization, identifying and driving continuous improvement initiatives and projects to enhance the sterility assurance and microbiological activities.
  • Evaluate and recommend new technologies, tools, and methods to enhance sterility assurance and microbiology.
  • Lead management reviews to assess the effectiveness of the sterility assurance program and microbiological program.
  • Lead and manage the sterility assurance and microbiology team, including hiring, training, coaching, professional development and performance evaluation.
  • Interact with external bodies & Global Quality to bring knowledge and awareness of best industry practices.
  • Prepare and participate in regulatory inspections and audits, providing expertise on sterility assurance and microbiology.

Requirements:

  • Degree and/or Master's in a science or engineering discipline.
  • Over 7 years of experience in the Pharma industry, with at least 4 years in a leadership role within aseptic/sterile manufacturing or Microbiology.
  • Proven experience in microbiology and sterile manufacturing.
  • Strong leadership and experience in developing and mentoring technical teams.
  • Expertise in aseptic manufacturing, regulatory requirements and product technical transfer.
  • Strong communication, decision-making, and analytical skills.
  • Proficient in Lean Principles and process control strategies to enhance operational effectiveness.

Contact:

If you would like to learn more about the vacancy, apply now, or contact Brendan Mullins on +353 61 527 150 or Bmullins@elusav.com

#J-18808-Ljbffr

  • Cork, Cork, Ireland Elusav Recruitment Full time

    Head of Sterility Assurance and MicrobiologyElusav Recruitment has an amazing opportunity for a Head of Sterility Assurance and Microbiology with a leading global biopharma company in Waterford, Ireland.Responsibilities:Develop and implement comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision,...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    Take on a challenging role as a Director of Microbiological Operations with a leading global biopharma company in Waterford, Ireland. In this position, you will be responsible for developing and implementing comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives.As a key member of...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    Job DescriptionWe are seeking a highly experienced Head of Sterility Assurance and Microbiology to join our team at Elusav Recruitment. As a key member of our global biopharma company, you will be responsible for developing and implementing comprehensive sterility assurance and microbiological programs.Key Responsibilities:Develop and Implement...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    Join our esteemed client's team as a Sterility Assurance and Microbiology Lead. As a critical member of their senior management team, you will develop and implement effective strategies and procedures for sterility assurance and microbiology across the organization. Key responsibilities include ensuring the compliance of products and processes with...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    About the PositionWe are seeking a highly experienced Head of Sterility Assurance and Microbiology to join our team at Elusav Recruitment.Key ResponsibilitiesDevelop and implement comprehensive sterility assurance and microbiological programs.Ensure compliance with applicable sterility assurance and microbiology regulatory requirements and company quality...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    Sterility Assurance and Microbiology Leadership OpportunityWe have an exciting opportunity for a Head of Sterility Assurance and Microbiology to join our global biopharma client in Waterford, Ireland.About the RoleDevelop and implement comprehensive sterility assurance and microbiological programs.Ensure compliance with applicable sterility assurance and...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    Elusav Recruitment presents a remarkable opportunity for a Head of Sterility Assurance and Microbiology. The selected candidate will be responsible for developing and implementing comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives.A key aspect of this role is ensuring...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    Lead the way as a Head of Sterility and Quality Assurance with a leading global biopharma company in Waterford, Ireland. In this position, you will be responsible for developing and implementing comprehensive sterility assurance and microbiological programs in alignment with the organizational strategy, vision, and objectives.As a key member of the senior...


  • Cork, Cork, Ireland TN Ireland Full time

    The Biocompatibility and Sterility Assurance Lead will play a critical role in ensuring the quality and safety of Stryker's products.This role requires a high level of expertise in microbiology, biocompatibility, and sterility, as well as excellent communication and project management skills.Key ResponsibilitiesDevelop and implement strategies to ensure...


  • Cork, Cork, Ireland Elusav Recruitment Full time

    Elusav Recruitment OpportunityWe have an exciting opportunity for a Head of Sterility Assurance and Microbiology to join our global biopharma client in Waterford, Ireland.About the RoleDevelop and implement comprehensive sterility assurance and microbiological programs.Ensure compliance with applicable sterility assurance and microbiology regulatory...


  • Cork, Cork, Ireland Stryker Ireland, Ltd. Full time

    Work Flexibility: Hybrid Job Title Senior Manager, Sterility & Microbiology Reports To Senior Director of Quality Assurance Position Summary The  Senior Manager, Sterilization & Microbiology  will lead and develop a team of 4-7 microbiologists while ensuring completion of all microbiological and bio-analytical testing. You will be...


  • Cork, Cork, Ireland TN Ireland Full time

    Social network you want to login/join with:Senior Manager Sterility / Microbiology, CorkClient: Stryker Ireland, Ltd.Location: Cork, IrelandJob Category: OtherEU work permit required: YesJob Reference: b14a0dcaa974Job Views: 75Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Work Flexibility: HybridJob Title: Senior Manager, Sterility &...


  • Cork, Cork, Ireland GE Healthcare Full time

    GE Healthcare Global Sterility Assurance Leader PDx Cork , Ireland Apply NowAs the Global Sterility Assurance Leader, you'll be responsible for the management and development of Sterility Assurance Programs and ensuring compliance with all sterility assurance regulations and industry best practices with specific emphasis on Annex 1 within Pharmaceutical...


  • Cork, Cork, Ireland GE Healthcare Full time

    GE Healthcare Global Sterility Assurance Leader PDx Cork , Ireland Apply NowAs the Global Sterility Assurance Leader, you'll be responsible for the management and development of Sterility Assurance Programs and ensuring compliance with all sterility assurance regulations and industry best practices with specific emphasis on Annex 1 within Pharmaceutical...


  • Cork, Cork, Ireland TN Ireland Full time

    We are seeking a highly skilled Microbiology Compliance Specialist to join our team at TN Ireland.In this role, you will be responsible for ensuring the biocompatibility, microbiological, and sterility compliance of Stryker's products in accordance with relevant regulatory requirements and standards for medical devices.Key ResponsibilitiesEvaluate new...


  • Cork, Cork, Ireland Prochem Engineering Full time

    Position OverviewWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Prochem Engineering.Key Responsibilities:Execution of QC-Micro testing (water sampling, water testing, growth promotion, identifications, Sterility testing, Environmental monitoring, and plate reading) as required.Compliance with cGMP and...


  • Cork, Cork, Ireland GE Healthcare Full time

    Job SummaryThe Global Sterility Assurance Leader will be responsible for the management and development of Sterility Assurance Programs, ensuring compliance with sterility assurance regulations and industry best practices. This role will either report to the Senior Director Global Compliance & Quality Systems or the Global Quality Risk Management &...


  • Cork, Cork, Ireland PE Global Full time

    We are seeking an experienced Microbiological Assurance Lead to join our client's team in Cork.The successful candidate will be responsible for developing and implementing strategies to reduce contamination risk and improve microbiological hygiene within the operations department.Conduct routine area walkdowns and GEMBA's to monitor the quality of the work...


  • Cork, Cork, Ireland BioMarin Full time

    QC Analyst- Sterility Team – 6 months Exciting new role in the newly approved sterility test lab within the QC team at BioMarin. This role will be focused on supporting primary component packaging, microbiology and sterility testing support the new Drug product facility in BioMarin. QC Sterility are a high performing team-based group. The team is...

  • Microbiology Analyst

    2 weeks ago


    Cork, Cork, Ireland TN Ireland Full time

    On behalf of our Manufacturing Client in Cashel, Co Tipperary, we are currently sourcing a Microbiology Analyst to join their Team.Job Duties:Lead Environmental Monitoring Program and any associated risk assessments.Complete validation of equipment and test methods for microbiological tests.Growth Promotion Testing and Culture Management.Microbial Limit...