Bristol Myers Squibb · 18 hours ago
Quality Specialist, PDQ Quality Operations Support
New Brunswick, NJ
Full-time
Onsite
Mid Level
$84K/yr - $102K/yr
3+ years expBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. They are seeking a Quality Specialist to provide oversight during Clinical Supply Operations, ensuring compliance with Good Manufacturing Practices and supporting quality assurance activities.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Performs QA Manufacturing Support Program activities and upholds the program's principles and initiatives. Performs program implementation throughout CSO and other GMP support areas
Perform walkthroughs and spot checks of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs
Perform parenteral AQL inspections
Responsible for timely release of raw materials, and components
Assists in the management of change notification and complaints from suppliers to conform cGMPs as applicable
Support periodic assessment of Clinical Supply Operations for Global Audit and Regulatory Agency inspection readiness
Evaluate and respond to observation and CAPA trends to ensure compliance with cGMP regulations and BMS procedures
Provides instruction and guidance on quality issues and serves as a resource for the site. Supports site operations during regulatory agency and third party inspections
Supports continuous improvement initiatives and drives simplification of processes
Adherence to BMS core behaviors
Qualification
Required
Knowledge of science generally attained through studies resulting in a B.S., in chemistry, pharmacy or biology or a related pharmaceutical science
Minimum of 3-5 years' experience in pharmaceutical quality
Demonstrated effectiveness in quality assurance operation and compliance of clinical drug product and supplier management in an FDA and EMA regulated environment
Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations as they apply to clinical supplies
Demonstrated leadership, interpersonal, communication, and motivation skills
Ability to provide innovative, compliant ideas or alternate approaches which create value
Ability to work on multiple projects/initiatives at any given time
Highly collaborative, possess a track record of building and maintaining cross-functional relationships, and able to communicate effectively
Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance
Demonstrates knowledge and experience in cGMP regulations
Proficient in Desktop Applications (MS Word/Excel/PowerPoint/SharePoint)
Excellent verbal and written communication skills
Strong Interpersonal and organizational skills
Preferred
Experience in R&D environment is highly desirable
Benefits
Health Coverage Medical, pharmacy, dental, and vision care.
Wellbeing Support Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
Company data provided by crunchbase