Senior Specialist, QC Systems and Support

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.

Position Summary

The Senior Specialist QC Systems and Support is responsible for maintaining QC laboratory equipment in a cGMP-compliant state and ensuring the integrity of equipment-related data, systems, and processes throughout the equipment lifecycle. This function is the Subject matter expert (SME) for QC equipment qualification, computerized systems, and data integrity, supporting first-line troubleshooting and regulatory inspections. Responsibilities include tracking, trending, and reporting QC equipment key performance metrics and leading continuous improvement initiatives. This role interfaces cross-functionally with QC laboratories, Facilities & Engineering and Quality Assurance to drive operational excellence in a fast-paced, highly regulated cell therapy manufacturing environment.

Duties/Responsibilities

• As system owner, accountable for the full QC equipment lifecycle (including validation, qualification, calibration, preventive maintenance, and repairs) ensuring equipment remains in a cGMP-compliant state in accordance with GMP requirements and written procedures, in collaboration with Facilities & Engineering

• Own and oversee processes associated with QC equipment in computerized systems (e.g. VLMS, EAM), ensuring alignment with GMP and data integrity requirements in partnership with relevant system stakeholders

• Manage QC Alarm processes, ensuring timely review, escalation, and resolution of equipment and system alarms in accordance with GMP requirements

• Track, trend, and report KPIs related to QC equipment reliability, availability, and compliance, driving accountability and performance visibility across stakeholders

• Accountable for data integrity (DI) compliance for QC laboratory equipment and processes, ensuring adherence to ALCOA+ principles across all equipment-generated data

• Lead continuous improvement initiatives associated with QC equipment

• Author, review, and approve technical documents, SOPs, qualification protocols/reports, and GMP records

• Own, lead, and manage Change Controls, Deviations, Investigations, and CAPAs related to QC equipment and systems

• Support first-line troubleshooting for equipment issues

• Support internal and external GMP inspections as SME for QC systems, equipment, and data integrity

• Train and mentor peers on equipment processes, data integrity principles, and QC systems operations

• Perform additional tasks as required to support QC laboratory operations

Qualifications

Specific Knowledge, Skills, Abilities:

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.

• Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.

• Attention to detail and demonstrated organizational skills.

• Ability to work in a fast-paced team environment, meet deadlines and changing priorities.

• Problem-solving ability/mentality, technically adept and logical

• Ability to apply Lean, Six Sigma and Risk Management concepts and tools preferred.

Education/Experience/ Licenses/Certifications:

• Bachelor's degree (BSc) in a life science, chemistry, or related scientific discipline preferred, MLO Level 4 or equivalent combination of relevant education and professional experience will be considered

• 4+ years of relevant laboratory experience in a GMP-regulated environment, preferably within pharmaceutical, biotech, or cell/gene therapy manufacturing

• Demonstrated hands-on experience with:

• Equipment qualification and validation (IQ/OQ/PQ)

• Data integrity principles and implementation (ALCOA+, 21 CFR Part 11, EU Annex 11)

• Quality Management Systems (QMS), including CAPA, deviation, and change control management

• Working knowledge and practical application of data integrity regulations and guidelines

• Advanced proficiency with computerized systems and enterprise applications (VLMS, LIMS, EAM or equivalent)

#LI-Onsite

Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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.

Supporting People with Disabilities

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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602402 : Senior Specialist, QC Systems and Support