Senior Specialist, Quality Systems & Compliance

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.

Title: Senior Specialist, Quality Systems & Compliance

Location: Warren, NJ

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 Senior Specialist, Quality Systems, is responsible for supporting the ownership and oversight of Quality Systems such as document control, internal audit, quality risk management, data integrity, quality council and local process ownership per established local and global standards. This position supports Compliance & Quality Systems initiatives as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities.

Key Responsibilities:

• Participate in site internal audit program and support global audits/inspections.
• Report on compliance state of various systems including deviations, corrective actions, and change management associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
• Ensure document control and records management systems are robust and adequately address requirements and risks
• Support the administration and maintenance of Site Quality Council, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation, as needed.
• Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.
• Lead meetings and represent function at cross functional and network meetings.
• Identify improvement opportunities and drive team continuous improvement goals and projects related to Warren Quality Systems such as records management, document control, internal audit, and risk management.
• Support internal and external inspections.
• May act as subject matter expert and Quality System programs overview and related topics during audits.
• Maintain compliance with assigned learning plan. 
• Support integration of newer team members
• Lead meetings and represent function at cross functional meetings . Share data/ knowledge within and across teams. Build & maintain strong relationships with partner functions.

Qualifications & Experience:

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 4+ years of experience in a regulated industry, preferably with 1+  year of quality system experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. 
• Demonstrated proficiency with electronic system and databases

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
• Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed actions
• Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles
• Excellent verb