Senior Quality Systems Manager

Manage and partner with the Corporate CAPA Pillar (CAPA, NCEP and PIR) Stewards in development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of processes and systems conform to establish standards and agency guidelines. Ensures appropriate quality system processes are maintained and followed in support of Corporate and Site quality objectives. Your responsibilities will include: Manages Corporate CAPA portfolio ensuring a high-quality standard and in line with applicable Management Review metrics. Provides guidance to eCAPA users globally related to CAPA and NCEP management and escalation. Support Corporate and site level internal and external audit as needed. Provide guidance and expertise regarding audit strategies and approaches. Implements training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture. Ensures implementation of CAPA, NCEP and PIR processes and other functional excellence initiatives in Quality, including integration activities. Bachelor's degree in relevant field Minimum of 5 years CAPA/NCEP, or equivalent, experience Proven leadership success through direct supervisory experience or experience leading cross-functional teams, implementing strategies, and achieving measurable results Understanding of regulations and standards applicable to the BSC Global Quality System and CAPA, NCEP and PIR processes (ISO 13485, 21 CFR 820, EU MDR, etc.) Experience with CAPA and CAPA concepts Strong verbal, written communication skills, both technical and conversational Provide guidance to BSC quality system teams globally on CAPA and NCP processes Ability to work well under pressure, with multiple high priority deliverables Decision making and negotiation skills, individually and within groups Experience in managing multiple projects across multiple organizational disciplines Experience with major systems (e.g. eCAPA, Windchill, VIP) desirable Strong presentation skills and MS Office skills Strong analytical skills