Senior Manager, Global QA Patient Operations And Regulatory Vigilance (m/f/d)

Global QA Apheresis Compliance Senior Manager

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

The primary responsibility of the Global QA Apheresis Compliance Senior Manager is to establish and maintain a Regulatory Vigilance Program related to Apheresis Collection activities by assessing the Compliance to the Regulatory and BMS requirements, by identifying Quality/Regulatory risks and by mitigating them.

Duties/Responsibilities

• Participate on the development, implementation and maintenance of department Standards, SOPs, and Guidance documents.
• Stays abreast of current global regulations; updates SOPs and Guidance documents as required.
• Leads or participates 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. This Global Regulatory Vigilance Program may include new/updates to applicable regulatory standards, relevant Health Authorities commitments/requirements, local applicable regulations. This program should include prioritization of the identified Quality/Regulatory risk actions.
• Identify and review new /updated Regulatory Standards applicable for the Apheresis Collection activities and contribute to the GxP Compliance Reviews (comparing implemented BMS requirements to the actual and/or upcoming industry practice/regulatory standards).
• Participate to the establishment and execution of the maintenance of Regulatory Requirements repository tools for existing and new countries.
• Collaborate/Coordinate with other BMS Compliance/Regulatory units to ensure that relevant internal/external requirements/commitments are appropriately implemented in established procedures related to Apheresis Collection activities.
• Interact with cross-functional teams to identify Regulatory gaps and propose solutions to address them and/or to capture them as actions into the Regulatory Vigilance Program.

Other Responsibilities

• Support the 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 Human Tissue (Quality and Safety for Human Application) Regulations 2007
• Appointed as SwissMedic (Switzerland) deputy Responsible Person (RP) according to the Swiss Medicinal Products Licensing Ordinance (SR 812.212.7) and Responsible Person requirements technical interpretation (I.SMI.TI.17) for clinical and commercial purposes (I and H/V) and Quality Oversight for the following activities

Qualifications

• Specific Knowledge, Skills, Abilities: Ability to think clearly and act in a decisive manner; communicate difficult observations in a calm and cogent manner. Interpersonal skills: excellent communicator, coaches and inspires people to achieve team goals, delivers training to achieve and keep state of the art knowledge, establishes a collaborative environment, and manage interfaces well with other units. Demonstrated ability to work independently or with groups of people/teams in a complex changing environment. Adaptable/flexible and able to deal with change. Enterprise mindset and external focus. Demonstrated negotiation, risk management, relationship management, and conflict resolution skills. In-depth knowledge of Global Health Authorities regulations, Quality Systems principles, and applications to the pharmaceutical industry.
• Education/Experience/ Licenses/Certifications: B.S. or advanced degree in a science or biopharmaceutical-related field or equivalent education/demonstrated experience. Minimum of 5+ years of experience in GMP/GDP/GTP Pharmaceutical/Biopharmaceutical Industry including Demonstrated experience managing and/or performing independent GTP or similar audits in both a clinical and commercial environment. Demonstrated experience interacting with global vendors, suppliers and/or CMOs. Large experience and technical knowledge in area as such as Pharmaceutical/Biopharmaceutical Manufacturing, Quality Assurance, Validation, Quality Control, Biotechnology, Facility & Utilities, Materials Management. This position requires up to 40% of travel.

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. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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