General Description:

This position will provide leadership and support for IT Systems that enable the BeiGene Hopewell U.S. Site Quality functions. They will partner with global and site leadership to provide scalable and sustainable technology solutions that support business strategy, realize value, and transform our ways of working. They will be responsible for reliable operation and implementation of Quality platforms and systems enabling the site.

This role works independently, with minimal supervision and direction, and will provide technical direction, project management support, commissioning and SME expertise in the areas of Quality, Quality Control and Quality Assurance. Projects may often require independent decision making and exercising of judgment.

This is an onsite role based in the Hopewell Site, NJ.

Essential Functions of the job:

• Serve as the GTS Site Quality Systems Lead and develop effective business relationships with key Quality leaders and stakeholders.

• Review and assess demand requests, explore new ideas and enhancements, evaluate legal/regulatory requirements relating to data integration and analytics.

• Lead and support projects in the design, development, and qualification of site quality systems; including managing the work of internal technical staff and outside vendors.

• Develop and review technical documentation.

• Ensure SDLC, testing, validation, training activities are followed and documented for system implementations.

• Support of various lab instrument applications.

• Hands-on experience with Laboratory information management systems (LIMS), Chromatography Data Systems (Empower), Environmental Monitoring systems, and Quality Management systems.

• Support the configuration, administration, and operational maintenance activities for site quality systems.

• Directly support operations with troubleshooting and issue resolution with respect to site quality systems.

• Lead small cross functional teams in support of small projects or initiatives.

• Requires working in an industrial manufacturing environment including gowning.

• Support operations and ensure compliance with regulatory, corporate and site requirements.

• Collaborate and work closely with Quality systems teams at other sites.

• The ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position. In addition, the ability for this person to develop and maintain transparent communication between departments is essential.

Other Qualifications:

• Bachelor’s degree in Engineering, Computer Science or related technological field

• Minimum 5 years of relevant work experience in building, configuring, and supporting Site Quality and Quality Control systems Strong

• Experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV).

• Previous experience in a GMP manufacturing or operations environment.

• Strong experience with at least one of the following platforms: Empower CDS, Thermo Fisher LIMS, MODA for Environmental Monitoring, Biovia LES/ELN

• Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.

• Experience in managing small to medium-sized projects and outside vendors. Effective written and verbal communications skills.    

Travel: Domestic and international travel less than 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.