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

This role is part of the site’s Quality Systems team an will focus on ensuring site readiness for internal and partner audits, as well as health authority inspections (FDA, EMA PMDA, etc.). The position will also be responsible for implementation, execution and maintenance of the site self-inspection program.

Education:

• Bachelor’s degree or equivalent

Experience:

• A minimum of 8 years of relevant Quality, compliance, or regulatory experience in a GMP/FDA regulated environment.
• Experience leading and performing internal or third party audits
• Management and participation in health authority inspections

Role Responsibility:

• Coordinate the end-to-end inspection readiness activities, including preparation and strategy sessions, interaction training for subject matter experts, and managing audit and inspection related logistics
• Ensure site personnel readiness by scheduling and conducting mock review sessions with subject matter experts
• Coordinate cross functional activities focusing on development, review, approval and submission of responses for inspection and audit findings
• Monitor and report status of remediation actions resulting from audit and inspection findings and drive efforts to ensure on-time completion
• Publish and report audit and inspection metrics in accordance to Quality Council Requirements
• Review, analyze and distribute regulatory inspection data and trending issued by regulatory authorities to ensure proactive compliance across the organization
• Develop and manage the inspection readiness annual plan, including identification of anticipated inspections
• Develop and manage the site self inspection schedule and ensure adherence to schedule.
• Conduct self inspection audits and compliance walk-throughs
• Coordinate document requests to support Health Authority Submission
• Coordination and submission of Biologic Product Deviation Reports
• Coordination and management of site notification to management program
• Identification and execution of continuous improvement initiatives within the Quality Systems Compliance programs

The starting compensation for this job is a range from $130,000 –$163,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

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WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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.

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.