The QC Operations Lead is responsible for the management of QC instruments/equipment, computer systems, sample management, and other project support functions.

Organization Deｓｃｒｉｐｔion

WuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development, and manufacture. An exciting new ａｄｄition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business moｄｅｌ on which WuXi Biologics reputation is based. Working within an integrated vaccine manufacturing facility with 240 million US Dollar investment, including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner’s vaccine products for the global market.

Department Deｓｃｒｉｐｔion

As QC Operations Lead you’ll 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 you’ll be reporting to the Head of QC.

Responsibilities

In this role, you will be responsible for:

? Management of QC instruments, equipment, and systems, including: equipment installation, qualification, and computer systems validation

? Issue and control calibration and PM logbooks and instrument/equipment labels (instrument identification and calibration)

? Maintain maintenance/calibration schedules, performing maintenance/calibration and requalification of instruments (if applicable), coorindating the repair and instrument/equipment calibration

? Sample management, including: sample log-in and disposition (internal and external), routine inventory checks, respond to temperature excursion alarms

? Author technical documents, including relevant SOPs, testing protocols and reports (i.e. in-process testing, release, and stability), product specifications, product expiries

? Serve as a technical lead in applicable deviations, change controls, and CAPAs

? Represent Operations team in regulatory inspections and client and internal audits

? Recruit, train, and retain a high performance team of 8-10 total headｃｏｕｎｔ

? Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations

? Ensure the tasks associated with the start up and routine operations applicable to the role are carried out in a safe manner

? Enhance collaborations by sharing knowledge and experiences across WuXi Vaccines global sites

? Thorough understanding of current Good Manufacturing Practices

? Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence

? Perform ａｄｄitional duties at the request of the direct supervisor

The ideal candidate for this position, will have the following:

Education

Ph.D. with 5-8 years of experience, or ｍａｓｔｅｒs with 7-10 years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field

Knowledge/Experience

Experience with LIMS, Empower, ECM, ｍａｓｔｅｒ Control, Trackwise, Maximo

Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project

Management/supervision of personnel with particular attention to schedules and shifting priorities

Knowlegable of FDA/EMA regulatory requirements and ICH and GMP guiｄｅｌines applicable to biologics and/or pharmaceuticals

Previous experience in a Quality Control/GMP environment is required

Prevoius experience with regulatory inspections and internal/customer audits is strongly preferred

Previous experience working in a CMO is a plus

Excellent interpersonal, verbal, and written commumication 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 changing priorities

Up to 15% domestic and international travel

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 mission - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

上班地址：-江苏-苏州-苏州生物医药产业园星湖街218号