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Job Details


Bristol Myers Squibb

Manager, Quality Assurance Batch Record Review

Technology

Quality Assurance

No

Summit, New Jersey, United States

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

The QA Manager is responsible for supervising the overall activities of QA Batch Record Review group ensuring the accurate and timely review of the manufacturing batch records in accordance with BMS policies, standards, procedures and Global cGMPs, and accurate review of investigations, CAPA and Change Controls. Additionally, the QA Manager will be responsible for continuous improvements, ownership of change management records within the QA department and providing support for trending of quality compliance metrics.

(Wed-Sat 2nd shift 1:00pm - 11:30pm)

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
    • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
    • Requires minimal direction to complete tasks. Completes routine tasks with little or no supervision.
    • Confident in making decisions for non-routine issues.
    • Must be skilled in planning and organizing, decision-making, and building relationships.
    • Advanced ability to interpret results and situations and articulate recommendations for resolution.
    • Is recognized Subject Matter Expert within the group.
    • Understands continuous improvement and improves efficiency and productivity within the group or project.
    • Able to recognize conflict and notify management with proposed recommendations for resolution.
    • Able to prepare written communications and communicate problems to management with clarity and accuracy.
    • Knowledge of US and global cGMP requirements.
    • Excellent verbal and written communication skills

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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