Qa Lead Drug Substance Manufacturing

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 company has sites/offices in China, US, EU and company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.
Job description: QA Lead Drug Substance (DS) Manufacturing- Associate Director A critical role within the QA organisation, the QA Drug Substance (DS) Manufacture Lead will lead the QA team.
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 WuXi Biologics Ireland.
Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries.
Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform.
We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Department Description As QA DS Manufacture Lead, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
In this role youll be reporting to the Director of Quality, WuXi Biologics.
Your Responsibilities In this role, you will: 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 WuXi Biologics corporate core values and PROUD culture.
Your Profile The ideal candidate for this position, will have the following: Education: A Bachelors degree in a technical discipline (e.g., biochemistry, chemistry, engineering) would be an advantage.
Knowledge/Experience Required: 8 plus 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.
Personal skills 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.
Other 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.
There will be a requirement for direct reports to work shift pattern once the project phase is complete.
Delegation of Responsibilities When absent from the site, duties and responsibilities (with exception of QP confirmation/ certification of biologics drug substance) will be delegated to the following designates: Job Title: Senior Director of Quality Job Title: QA Drug Substance Group Leader, QA for WH Group Lead As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
Reach beyond yourself and discover your true potential
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.
Apply now
Would you like to know more before you apply?
Please visit us at or contact us via WuXi Biologics is an equal opportunities employer.
Skills: Problem Solving Analytical skills Attention to Detail Leadership Management Benefits: Bonus Educational assistance Life Assurance Parking Pension VHI