Principal Specialist, Quality Risk Management

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 rich in diversity.

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 .

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure.

If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The Principal Specialist Quality Risk Management CAR T is responsible for supporting the S-12 Cell Therapy Quality Risk Management Program in accordance with BMS policies, standards, procedures and global cGMPs.

The primary focus for this role is to facilitate the risk assessments, in order to identify risk areas and implement risk mitigation measures for S-12 operations, cGMP compliance and business continuity.

Additionally, this role is responsible to maintain quality risk management program deliverables and facilitate complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions.

As a member of the Quality Assurance Organization, this position is working closely with the S-12 Quality Risk Management leadership and other company risk management stakeholders, to identify and provide solutions to cGMP related issues and escalate them as appropriate to ensure the site remains in a state of control.

Shift Available :

Monday - Friday, Hybrid Day Shift (8 a.m. - 5 p.m.)

Responsibilities :

• The primary responsibilities of the Principal Specialist Quality Risk Management are to evaluate and implement a plan to mitigate process and / or product risks and to support cross functional departments on risk identification, root cause analysis and investigative measures.
• Contribute to the writing, coordination, review, approval and maintenance of the S12 Risk Management Standard Operating Procedures (SOPs) and associated documentation.
• Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.
• Evaluate and report key performance metrics, analyze data and lead improvement initiatives.
• Facilitate planning, execution and completion of risk assessments by providing direction, and guidance to cross functional teams.
• Ensure product risk management documentation / files are maintained, with good documentation practices and in compliance with S-12 Quality System.
• Partner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse and Safety.
• Drive continuous improvement for effective risk management and to address recurring issues identified throughout S-12.
• Track and verify appropriate corrective actions have been implemented, documented and align with source event.
• Maintain S12 Quality Risk Register and track the status of risk mitigation actions through to completion.
• Schedule and facilitate S-12 risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.
• Conduct risk reviews and escalate findings, as appropriate, to S12 Risk Management Leadership with resolution and recommendations.
• Represent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.
• Work independently and perform with a high degree of accuracy.
• Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices.
• Proactively learn, develop and customize methods and techniques (e.g. Six Sigma / Lean, FMEA, Root Cause Analysis, etc.

to improve effectiveness of the Risk Management program.

Knowledge & Skills :

• Experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.
• Proven experience working as a detailed oriented team player with effective planning, organization and execution skills.
• Experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc.).
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
• Able to manage multiple priorities.
• Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
• Ability to make independent and objective decisions, and to work with minimal supervision.
• Must be able to interact with multidiscipline departments and Cell Therapy Development & Operations (CTDO) sites.
• Must possess an independent mindset and tenacity.
• Must be skilled in planning and organizing, coaching others, decision-making and building relationships.
• Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
• Ability to work effectively across functional groups and teams to ensure requirements are met.
• Excellent verbal and communication skills.

Basic Requirements :

• Bachelor's degree in science required; advanced degree preferred.
• 5 years of experience within the pharmaceutical or biotech industry.
• 5 years within a Quality role.
• 3-5 years of experience in Quality Risk Management in a cGMP / FDA regulated environment regulated environment such as manufacturing / QC or QA.
• 2-3 years of experience in change control.

Preferred Requirements :

• Experience in CAR T or Biologics preferred.
• Professional certification in Quality Risk Management preferred.

BMSCART, #LI-Hybrid

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 an inclusive culture, promoting diversity 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 a diverse 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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