Overview Senior Manager, Global QA Patient Operations and Regulatory Vigilance (m/f/d)
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.
Regulatory Vigilance Process
Participate in the establishment and execution of the maintenance of a Global Regulatory Vigilance Program (all regions) related to Apheresis Collection activities, including updates to regulatory standards and Health Authority commitments; prioritize identified quality/regulatory risk actions.
Identify and review new or updated regulatory standards applicable to Apheresis Collection activities and contribute to GxP compliance reviews (comparing implemented BMS requirements to current and upcoming industry practice/regulatory standards).
Establish and maintain Regulatory Requirements repository tools for existing and new countries.
Collaborate with other BMS Compliance/Regulatory units to ensure relevant internal/external requirements/commitments are implemented in procedures related to Apheresis Collection.
Interact with cross-functional teams to identify regulatory gaps and propose solutions, capturing actions in the Regulatory Vigilance Program.
Other Responsibilities
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) according to regulations for Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Appointed as SwissMedic (Switzerland) deputy Responsible Person (RP) and Responsible Person requirements for clinical and commercial purposes, with quality oversight for related activities.
Qualifications Specific Knowledge, Skills, Abilities:
Ability to think clearly and act decisively; communicate difficult observations calmly and cogently.
Interpersonal skills: excellent communicator, coaches and inspires teams, delivers training to maintain state-of-the-art knowledge, fosters collaboration, and manages interfaces with other units.
Ability to work independently or with groups in a complex, changing environment.
Adaptable/flexible and able to handle change.
Enterprise mindset and external focus.
Negotiation, risk management, relationship management and conflict resolution skills.
In-depth knowledge of Global Health Authority regulations, Quality Systems, and pharmaceutical industry applications.
Education/Experience/Licenses/Certifications:
B.S. or advanced degree in a science or biopharmaceutical-related field or equivalent experience.
Minimum of 5+ years of experience in GMP/GDP/GTP pharmaceutical/biopharmaceutical industry, including audits in clinical and commercial environments.
Experience managing and/or performing independent GTP or similar audits.
Experience interacting with global vendors, suppliers and/or CMOs.
Skills in planning and organizing, conflict management, coaching, talent development, decision-making, relationship building, innovation management, and resource allocation.
Extensive knowledge in areas such as Pharmaceutical/Biopharmaceutical Manufacturing, Quality Assurance, Validation, Quality Control, Biotechnology, Facility & Utilities, Materials Management.
Travel: up to 40%.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
On-site Protocol and Other Information Responsibilities and occupancy structure define where you work (site-essential, site-by-design, field-based, remote-by-design). Site-essential roles require 100% onsite; site-by-design roles may be hybrid with at least 50% onsite. Field-based/remote roles require ability to travel to visit customers, patients or partners as directed.
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BMS recommends vaccination against Covid-19 and up-to-date boosters. Employment consideration may be subject to applicable laws regarding arrest/conviction records. For California residents, visit careers.bms.com/california-residents/ for additional information. Data processed in role applications will be treated in accordance with applicable data privacy policies.
Seniority level Mid-Senior level
Employment type Full-time
Job function Other
Industries: Pharmaceutical Manufacturing
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