QC Operations Team Lead

As QC Operations Team Lead (FTC 12 months) you will be responsible for ill be responsible for carrying out tasks and projects relating to QC instruments/equipment computer systems sample management and general QC-compliance functions while ensuring the highest standards of Good Laboratory Practices regulatory requirements and quality within the business is adhered to. As part of the project the role will evolve based on project timelines.

Organisation 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 worlds 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.

Our mission is to accelerate and transform discovery development and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China the US the EU and Asia. We currently employ over 10000 people and provide services to more than 600 customers worldwide including the top 20 biopharmaceutical companies.

Department Description

As QC Operations Team Lead youll be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing this role youll be reporting to the QC Operations Lead (Associate Director).

Essential Duties and Responsibilities

• Key member of the QC Team in Dundalk. Will support execution of the strategy and business planningprocesses ensuring cross-functional collaboration.

• Achieve a high level of competency in laboratory methods and procedures to support raw material utility in process release and stability testing of biotechnology products.
• Provide effective communication and play a leading role in project management interaction with internaland external clients such as Quality Assurance Regulatory Affairs and Analytical Development.

• Perform routine and non-routine testing activities as required.
• Ensure that all testing is completed reviewed and approved within agreed turnaround times.
• Ensure QC activities are carried out in compliance with product license commitments cGMP and company quality standards.
• Train other QC analysts and Manufacturing personnel in laboratory methods and procedures whenrequired.

• Write/update and review TMs (Test Methods) SOPs (Standard Operating Procedures) and WIs (WorkInstructions) as required.

• Write and review invalid tests non-conformances and deviations as required.
• Initiate and drive change controls to completion to implement process improvements.
• Actively participates in lean initiatives such as Kaizen 5S and Gemba.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Associate Director of QC Operations.
• Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.

Person Specification

Technical Competencies

• Experience working in a QC function in a greenfield context of similar size and scale is ideal.
• Expertise in the release of GMP materials and participant in QC activities such as method transfer
• validation etc.
• Experience in Biopharma analysis is desirable.
• Experience with LIMS Empower etc is desirable.
• Experience troubleshooting in testing issue resolution is desirable.
• Experience in method transfers is desirable.

Experience

• Experience working within a Quality Control environment with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
• Previous experience managing and leading a small team would be advantageous.
• Experience with LIMS Empower ECM Master Control Trackwise or similar systems is required.
• Experience with Microsoft Word Excel Powerpoint Visio and Project is required.
• Management/supervision of personnel with particular attention to schedules and shifting priorities is

desirable.

• Previous experience working in a CMO is an advantage.

Knowledge

• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
• Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable tobiologics and/or pharmaceuticals.

Qualifications

• University degree in related science/quality discipline required.

Behavioural Competencies

• Strong leadership competencies with demonstrated management skills.
• Excellent interpersonal verbal and written communication skills.
• Able to think critically and demonstrate troubleshooting and problem-solving skills.
• Self-starter and self-motivated; organized with good attention to detail.
• Comfortable working in a fast-paced environment and able to adjust workloads based on changingpriorities.
• Results oriented with the ability to manage multiple priorities in a short period of time.
• Collaborative and inclusive approach to work and your colleagues.

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!

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WuXi Biologics is an equal opportunities employer.