Senior Manager, Quality Risk Analyst

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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more : careers.bms.com / working-with-us .

Key Responsibilities

• Help to develop the Quality Narrative at a study and TA level, to document the end-to-end risk-based quality management for critical to quality (CtQ) data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the Risk Based Monitoring (RBM) framework Clinical Oversight and Risk Management (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections.
• Work with Drug Development, particularly the CORM function, to embed Quality by Design principles and help identify study specific CtQ data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• Provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
• At the study level, conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans and verification of action plans are implemented for risk mitigation.
• Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
• Partner with the study teams to ensure effective management of significant quality issues / noncompliance and important protocol deviations for CtQ data, processes and vendors.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
• Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.
• Capture GxP (GCP) Non-compliance events and conduct trend analysis documenting accordingly .
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project / products, to the business and Health Authorities, as needed.
• Ensure compliance with ICH (E6, E8, E9) and other relevant regulatory requirements.
• Involved in External engagement as needed with industry / trade / QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.

Other

Qualifications & Experience

Degree / Certification / Licensure

Experience - Responsibility and minimum number of years :

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

Responsibilities

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 [HIDDEN TEXT] . 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 /

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Skills Required

analytical support , Gxp, Process Improvement, clinical risk management , Trend Analysis, Capa, Regulatory Compliance, Gcp, Qms, Quality Management