QA Drug Substance Manufacture Lead

Our client is a leading provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. They are a global contract development and manufacturing company for biopharmaceuticals; they provide their clients with a world-leading open access technology platform. They enable their clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Due to an internal promotion, they are currently seeking to fill a critical role within the QA department. The QA Drug Substance Manufacture Lead will lead the QA team on site in Louth. Responsible for ensuring that biologic drug substance manufacturing is performed in compliance to cGMP, site SOPs and controlled documents from end-to-end, covering warehouse and supply chain management operations, manufacturing operations, batch certification by QP, batch release and shipment for biologics drug substance manufactured in their Biologics facility in Ireland.You will be reporting to the Senior Director of Quality who is also based in Ireland.

As they extend their global reach, they require someone who is interested in change, in challenge, and in building a new future together.

Role/Responsibilities

• Lead the QA teams responsible for 24/7 oversight of Warehouse and Supply Chain Management (SCM), Drug Substance Manufacturing Operations and the QA team responsible for batch disposition operations.
• Develop, implement, and monitor the quality systems relating to warehouse, SCM and manufacturing and batch disposition operations.
• Provide QA review and approval of SOPs, master batch records, quality risk assessments, change controls and other documentation, as applicable, associated with Manufacturing, Warehouse, SCM and batch disposition operations.
• Review and approve deviation reports, CAPAs, and technical documents to support GMP decisions and batch disposition.
• Ensure online QA presence in Warehouse and Manufacturing areas during operation, as required.
• Lead the GMP Release program.
• Liaise with internal and external teams, as appropriate, to ensure that all deviations, investigations, and batch record review comments are adequately addressed and closed out in a timely manner as defined in SOPs.
• Liaise with internal and external teams, as appropriate, to ensure that all CAPAs, change controls, internal audit observations are addressed and closed out in the required time frame.
• Ensure timely and efficient disposition of biologics drug substance batches.
• Supervise direct reports on a day-to-day basis, provide training and communications, assignment, and prioritisation of work.
• 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 SME for QA DS function during regulatory inspections and Client audits, prepare responses to observations, monitor implementation of follow-up actions.
• Lead and/or represent QA on multidisciplinary teams including New Product Introduction (NPI), Technology Transfer and continual improvement projects.
• Perform internal and external audits, as required.
• Identify and drive opportunities for continuous improvement.
• Champion site metrics and KPIs to ensure targets are achieved, met and counter measures in place when applicable.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Flexibility to take on additional tasks and responsibilities at the discretion of the Senior Director of Quality.
• Will act as a role model for the QA function and also the wider organisation in adherence to the corporate core values and culture.

• A Bachelor’s degree in a technical discipline (e.g., biochemistry, chemistry, engineering).

• 8 + years’ experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or similar.
• Candidates from Warehouse, Distribution (GDP) or Manufacturing Operations disciplines within the biotechnology and/or pharmaceutical industry will be considered but knowledge of Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required to be demonstrated.
• Experience managing a QA operations team would be an advantage.
• Experience in performing internal audits would be an advantage.
• Experience interacting the regulatory Inspectors would be an advantage.
• Experience working in a CMO in Client-facing role would be an advantage.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

• Strong technical aptitude (i.e., able to read & comprehend technical documentation & execute procedures).
• Strong knowledge of cGxP requirements and regulations.
• Knowledge of trouble shooting and problem-solving skills, e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
• Adaptable, able to multi-task and handle tasks with competing priorities effectively.
• Strong sense of urgency with a drive to close actions to closure on time and in full.
• Excellent interpersonal and communication skills.
• Excellent organisational skills.
• Proactive attitude.
• Excellent attention to detail.

• 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.
• There will be a requirement for direct reports to work shift pattern once the project phase is complete.