Drug Substance Manufacturing Quality Lead

5 days ago

Dundalk, Louth, Ireland beBeeQuality Full time €120,000 - €150,000

Job Summary

This is a critical role within the Quality Assurance organization responsible for ensuring that drug substance manufacturing is performed in compliance with current Good Manufacturing Practice, site Standard Operating Procedures and controlled documents.

The ideal candidate will lead a team responsible for 24/7 oversight of warehouse and supply chain management, drug substance manufacturing operations and batch disposition.

The successful candidate will have at least 8 years' experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in Quality Assurance or similar.

Demonstrated knowledge of quality management systems and continuous/process improvement tools is required.

Key Responsibilities:

  • Lead a team responsible for 24/7 oversight of warehouse and supply chain management, drug substance manufacturing operations and batch disposition.
  • Develop, implement and monitor quality systems relating to warehouse, supply chain management and manufacturing and batch disposition operations.
  • Provide review and approval of standard operating procedures, master batch records, quality risk assessments, change controls and other documentation associated with manufacturing, warehouse, supply chain management and batch disposition operations.
  • Review and approve deviation reports, corrective actions and technical documents to support good manufacturing practice decisions and batch disposition.
  • Ensure online quality presence in warehouse and manufacturing areas during operation, as required.
  • Lead the good manufacturing practice release program.
  • Liaise with internal and external teams to ensure that all deviations, investigations and batch record review comments are adequately addressed and closed out in a timely manner as defined in standard operating procedures.
  • Manage performance, delivery of objectives and career development of direct reports.
  • Ensure clear communication on issues and timely escalation, as applicable.
  • Support inspection/audit readiness activities, act as subject matter expert for Quality Assurance Drug Substance function during regulatory inspections and audits, prepare responses to observations, monitor implementation of follow-up actions.
  • Perform all duties in accordance with good manufacturing practice requirements, standard operating procedures and controlled documents.
  • Flexibility to take on additional tasks and responsibilities at the discretion of the Senior Director of Quality.

Requirements:

  • A bachelor's degree in a technical discipline would be advantageous.
  • At least 8 years' experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in Quality Assurance or similar.
  • Demonstrated knowledge of quality management systems and continuous/process improvement tools.
  • Personal skills: Strong technical aptitude, strong knowledge of cGxP requirements and regulations, knowledge of troubleshooting and problem-solving skills, adaptable, able to multitask and handle tasks with competing priorities effectively, excellent interpersonal and communication skills, excellent organizational skills, proactive attitude, excellent attention to detail.

Benefits:

  • Bonus
  • Educational assistance
  • Life assurance
  • Parking
  • Pension
  • VHI

Travel Requirements:

There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs.

Must be willing to travel when required.

Direct reports will work shift patterns once the project phase is complete.

  • Drug Substance Manufacturing Quality Assurance Lead

    24 hours ago

    Dundalk, Louth, Ireland beBeeQuality Full time €90,000 - €120,000

    Job Opportunity: Quality Assurance LeadWe are seeking a highly skilled Quality Assurance Lead to oversee the biologic drug substance manufacturing process.The successful candidate will be responsible for ensuring compliance with cGMP and site SOPs, leading a QA team to provide 24/7 oversight of Warehouse and Supply Chain Management (SCM), Drug Substance...

  • Qa Lead Drug Substance Manufacturing

    5 days ago

    Dundalk, Louth, 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...

  • Qa Lead Drug Substance Manufacturing

    4 days ago

    Dundalk, Louth, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: WuXi 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...

  • Qa Lead Drug Substance Manufacturing

    4 days ago

    Dundalk, Louth, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: WuXi 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...

  • Drug Substance Production Manager

    4 days ago

    Dundalk, Louth, Ireland beBeeManufacturing Full time €120,000 - €150,000

    Quality Assurance Lead for Biologic Drug Substance ManufacturingThis is a pivotal position within the quality assurance organisation, responsible for ensuring that biologic drug substance manufacturing processes are performed in accordance with cGMP, site standard operating procedures (SOPs) and controlled documents from end-to-end.About the Role:The role...

  • Senior Process Engineering and Cleaning Validation Expert

    6 days ago

    Dundalk, Louth, Ireland beBeeCleaning Full time €100,000 - €120,000

    Job OpportunityWe are seeking a highly skilled Senior Process Engineering and Cleaning Validation Professional to join our team.The successful candidate will play a key role in leading cleaning validation activities for the manufacture of biological bulk drug substance at our facility.This position requires strong leadership competencies, excellent...

  • Manufacturing Systems Specialist

    2 weeks ago

    Dundalk, Louth, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: WuXi 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...

  • Manufacturing Director

    2 weeks ago

    Dundalk, Louth, Ireland Wuxi Biologics Ireland Limited Full time

    Company description: WuXi 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...

  • Manufacturing Director

    2 days ago

    Dundalk, Louth, 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

    5 days ago

    Dundalk, Louth, Ireland WuXi Biologics Ireland Limited Full time

    Company description: WuXi 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...