QA Lead drug substance manufacturing
- 2ND Floor, Elgee Building, Magnet Rd, Townparks, Dundalk, Co. Louth, A91 YR9X, Ireland, County Louth (IRL)
- Negotiable
- Permanent
- Start date: 15 Jun 22
- Ref: 5082245
- management
QA Lead for Drug Substance Manufacture
Job Summary
This role will lead a team of QA Drug Substance Associates providing online QA oversight to MFG 6( (perfusion) Drug Substance manufacturing operations in WuXi Biologics Ireland in Dundalk, Ireland. This is a critical role within the Quality organisation with responsibility for supporting the manufacturing operations team, ensuring compliance with cGMP and corporate and local SOPs.
Essential Duties and Responsibilities:
- Lead a team of QA Drug Substance Associates providing QA oversight to technology transfer and commercial manufacturing for manufacturing operations.
- Supervise direct reports on a day-to-day basis, provide training and communications, assignment and prioritisation of work of direct reports.
- Manage performance, delivery of objectives and career development of direct reports
- Provide QA review and approval of SOPs, risk assessments, change controls and other documentation, as applicable, associated with Drug Substance manufacturing operations
- Ensure that Drug Substance manufacturing operations are conducted according to appropriate cGMP behaviours and compliance to SOPs, batch manufacturing records and other cGMP documentation, as applicable.
- Liaise with Manufacturing Operations to ensure that all deviations, investigations and batch manufacturing records review comments are adequately addressed and closed out in a timely manner as defined in SOPs.
- Work with Manufacturing Operations to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to manufacturing operations are addressed and closed out in the required time frame.
- Liaise with manufacturing operations, QA, QC, Engineering, MSAT etc. in supporting daily operations.
- Ensure clear communication on issues and timely escalation as applicable.
- Identify and drive opportunities for continuous improvement.
- Coordinate with internal Quality peers to ensure on-time disposition of drug substance material.
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
- Champion site metrics and KPIs to ensure targets are achieved, met and counter measures in place when applicable,
- Lead and/or represent QA on multidisciplinary teams, as required.
- Perform additional duties at the request of direct supervisor
Requirements:
- At least 8 years’ experience in the biotechnology and/or pharmaceutical industry within a Quality role, preferably in Operations support or similar.
- A Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering) would be an advantage.
- Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
- Demonstrated collaboration, negotiation & conflict resolution skills.
- Excellent communication skills (written and oral).
- Experience in performing internal audits.
- Exceptional analytical, problem solving & root-cause analysis skills.
- Ability to multi-task and handle tasks with competing priorities effectively to deliver site priorities.
- Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), and demonstrated experience interfacing with regulators.
- Excellent influencing/collaboration skills and teamwork mindset.
- Excellent trouble shooting and problem solving skills as well as an ability to coach and mentor teams through complex problems.
- Ability to challenge the status quo with a continuous improvement mindset.
- There may be a requirement for direct reports to work shift pattern once the project phase is complete.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Fred Chesne on +353 (85) 178 6539 or send your CV to fchesne@berkley-group.com
