Overview
Senior Manager, Global QA Patient Operations and Regulatory Vigilance (m/f/d) at Bristol Myers Squibb
Join to apply for the Senior Manager, Global QA Patient Operations and Regulatory Vigilance (m/f/d) role at Bristol Myers Squibb.
Responsibilities
Participate in the development, implementation and maintenance of department Standards, SOPs, and Guidance documents.
Stay abreast of current global regulations; update SOPs and Guidance documents as required.
Lead or participate in multi-disciplinary project teams as required.
Participate in, lead and/or observe audits as required to meet audit schedules, assure consistent department performance, and assess staff.
Establish and maintain a Global Regulatory Vigilance Program related to Apheresis Collection activities; assess regulatory requirements and identify/mitigate quality/regulatory risks.
Identify and review new or updated Regulatory Standards applicable to Apheresis; contribute to GxP Compliance Reviews (comparing BMS requirements to industry practice/regulatory standards).
Maintain Regulatory Requirements repository tools for existing and new countries.
Collaborate with other BMS Compliance/Regulatory units to ensure relevant requirements are implemented in procedures related to Apheresis Collection activities.
Interact with cross-functional teams to identify Regulatory gaps and propose solutions; capture actions into the Regulatory Vigilance Program.
Support launch activities of new products or new countries.
Provide front-room/back-room support during Health Authority Inspections as required.
Appointed as HTA (UK) Designated Individual (DI) under relevant regulations and as SwissMedic deputy Responsible Person (RP) for specified activities.
Qualifications
Education/Experience/Licenses/Certifications: B.S. or advanced degree in a science or biopharmaceutical-related field or equivalent; minimum 5+ years of GMP/GDP/GTP pharmaceutical/biopharmaceutical experience.
Experience managing and/or performing independent GTP or similar audits in clinical and commercial environments.
Experience interacting with global vendors, suppliers and/or CMOs.
Skills: planning and organizing, conflict management, coaching, leadership, decision-making, stakeholder management, and resource allocation.
Knowledge: Global Health Authorities regulations, Quality Systems principles.
Willingness to travel up to 40%.
Equal Opportunity and Additional Information
BMS is committed to balance and flexibility in the work environment. We provide a variety of competitive benefits and programs. Read more at careers.bms.com/eeo-accessibility.
On-site/remote work expectations vary by role; site-essential roles require onsite work, while others may offer hybrid or field-based arrangements. For accommodation requests, contact adastaffingsupport@bms.com. COVID-19 vaccination guidance is provided as part of health and safety considerations. This posting includes standard regulatory and safety information applicable to many locations.
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