QA Drug Substance Manufacture Lead

• 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.

Life Science Recruitment