Quality Specialist, PDQ Quality Operations 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.

Principal Objective of the Position

Provide Quality oversight during Clinical Supply Operations drug product and packaging and labeling manufacturing activities, and other GMP support areas.

Provide Quality on the floor in-Process support during manufacturing operations.

Assure the quality of manufactured products complies with all applicable regulations and guidelines. Performs QA manufacturing floor support activities within the Clinical Supply Operations areas to ensure compliance with all principle of current Good Manufacturing Practices (cGMP). Support material and component release for clinical drug product manufacturing.

Key Responsibilities and Major Duties

• 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.

 (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Professional Experience and Qualifications

• 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.
• Experience in R&D environment is highly desirable.
• 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 Interperson