• Senior Director, Quality Systems GTS

    BeOne Medicines (Pennington, NJ)


    General Description:

    The Senior Director GTS Quality will be the global GTS Business Partner and the primary interface between GTS and Global Quality. The individual will collaborate and partner with Global and Site quality functions and provide technology leadership and governance support for the Quality organization. The individual will lead the GTS strategy and provide holistic technology solutions that support business strategy, realize value, and transform our ways of working. The individual must ensure reliable deployment and operations of all Quality (QA & QC) platforms & systems for commercial manufacturing facilities. The individual must be a self-starter and demonstrate excellent teamwork and interpersonal skills, with the ability to communicate and collaborate with employees, partners, and management at all levels.

    Essential Functions of the job:

    + Serve as the GTS Quality Business Partner and interface with the global Quality organization and develop effective business relationships with key Quality leaders and stakeholders

    + Act as the principal interface between Quality and GTS to solicit and formulate and manage vendor proposals/ contracts, engage cross-functional stakeholders, execute technology projects

    + Develop strong collaborative relationships with Quality & GTS colleagues to leverage shared services where applicable, drive economies of scale and value realization through process and technology harmonization that aligns with the global GTS strategy

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

    + Lead/support projects and ongoing business-driven change initiatives leading to value driven business cases and well-defined implementation plans

    + Partner with key stakeholders to ensure robust investment governance and measuring project outcomes

    + Work closely with manufacturing sites to lead the development of business cases for programs and projects, define measurable business outcomes, deploy, maintain and support QA & QC solutions

    + Generate and maintain a strategic digital roadmap for the Quality capability, with ongoing demand management, resource management, release planning and drive incremental capabilities

    + Monitor external industry trends and supplier capabilities with a view for continuous improvement

    + Experience in developing strategies for new product introduction and new technology deployment

    + Support strategy, deployment and quality operations at the manufacturing plants in China & US

    + Understands the global Quality, risk, and regulatory environment to plan activities for compliance with existing and new regulations

    Supervisory Responsibilities:

    + Will have technical leadership or supervisory responsibilities over the GTS Quality team.

    + Strong team player who engages with peers to define, sponsor, and execute continuous improvements.

    + Solid leadership, technical writing, and communication/presentation skills

    + Strong experience in business analysis and process mapping

    + Ability to quickly assimilate knowledge of new platforms, languages, tools and technologies

    Education Required:

    Bachelor’s degree in Engineering, Computer Science or related technological field and minimum 10 years of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems, or

     

    Master’s Degree in Engineering, Computer Science or related technological field and minimum 7 years of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems.

    Other Qualifications:

    Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). Previous experience in a manufacturing or operations environment. Strong experience with any two of the following platforms: Veeva, LIMS, CDS and/or other Quality platforms. validation practices (GAMP). 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.

     

    **Travel:** Periodic domestic and international travel Less than 20%

     

    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.