Global Regulatory Compliance Senior Manager
About the position Responsibilities • Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule. • Partner with Quality leaders across the BSC network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data-driven, risk-based audit schedule. • Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs. • Act as the sub-process steward for the global Internal Audit process. • Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice. • Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture. • Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance. • Facilitate external audits through leadership in audit front rooms, back rooms, training for SME's, creation of storyboard material and site level support for Global procedures. • Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal. • Act as a CAPA owner for corrective actions necessary to improve the global processes. • Champion departmental or cross-functional quality initiatives. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Requirements • Minimum of Bachelor's degree in relevant field. • Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing. • Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.). • Demonstrated inclusive leadership skills. • High degree of integrity, professionalism, and the ability to establish credibility internally and externally. • High sense of urgency and commitment to execution. • Ability to travel up to 25 - 30% domestically and internationally. Nice-to-haves • Advanced degree. • Pharmaceutical experience. • Digital product ownership and/or IT project experience. • Strong analytical and communication skills. Benefits • Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). • Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). Apply tot his job