Leads global projects and/or programs which support various strategic initiatives within the Quality System. Responsibilities include all aspects of end-to-end project and/or program management within specific area of expertise. Actively collaborates with manufacturing sites, external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions in order to successfully deliver objectives. Provides regular updates and recommendations to senior leadership in order to drive an effective Quality System. Responsibilities • Develops project timelines, deliverables, conducts research analysis, monitors project status, and provides expertise for global projects/programs supporting strategic global Quality initiatives • Actively collaborates with cross-functional team to complete project milestones per established timeline. Leads meetings with cross-functional partners. • Utilizes expertise within GxP to review various types of content, such as external regulations or governing documents, and provide recommendations. • May create and manage project/program tasks within quality software system. • Builds and maintains collaborative partnerships with cross-functional stakeholders at all levels of the organization to understand business needs and incorporate these into assigned project/program decisions. • Manages end-to-end lifecycle of project/program, including driving team accountability, addressing project risks, driving effective decision making. • Creates and continuously improves meaningful metrics to demonstrate effectiveness and performance of assigned project/program. • Monitors changes in external regulations and project manages changes to internal processes accordingly. • Effectively delivers project or program status updates and recommendations for future strategic initiatives to senior leadership Qualifications • Bachelor's degree in Science/Engineering/Business Management or equivalent technical work experience • 5+ years of relevant Quality experience in a GMP pharmaceutical, biologics, and/or medical device manufacturing environment • Strong understanding of cGxPs, regulatory inspections, regulatory documents, global regulations, and standards • Experience in Project Management and leading cross-functional project teams with technical professionals in a global and/or complex, matrixed organization • Strong oral and written communication, interpersonal, time management, influence, and problem-solving skills • Proficient in the use of standard software applications including Office 365 • Validation experience with equipment, facility, utilities and/or process validation Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. • This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolutediscretion, consistent with applicable law.