Compliance Manager - Bristol Myers Squibb : Job Details

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.

Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently, and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.

This role is a key role in CSO organization to ensure day-to-day compliance within the organization as it pertains to GxP documentation, training, and other compliance activities performed in the team. The Compliance Manager will work with multiple departments across Product Development to communicate effectively on all compliance related issues.

Training and Documentation Content Management and Daily Support:

• Handle daily training and documentation tasks, queries independently ensuring compliance with GxP documentation and data integrity principles. Escalate technical and/or business issues promptly and follow through until resolved.
• Develop training curricula, evaluate/monitor training materials, record training activities and program effectiveness.
• Conduct training impact assessments, organize, and create training procedure guides and/or course materials and provide training to functional teams.
• Generate metrics for training, documentation, and other compliance related tasks. Ensure training and documentation data are properly captured, stored, archived, available, and maintained as per data integrity principles outlined in site procedures.
• Supervise/manage contingent workers/junior staff members on day-to-day documentation/training related task assignments as applicable.
• Create, review, and maintain CSO controlled documents (SOP, Forms, TIA, OJT, etc) as a content manager of various PD Electronic Document Management systems (ie PDHQ, BMS Docs-Veeva, Docman, etc).
• Support activities related to periodic reviews, CAPAs, and maintenance of CSO-controlled GxP documents (CVs, JDs, signature logs, forms, DIRAs, Risk Assessments).
• Support all data integrity related work as assigned.
• Ensure compliance related GMP documents are issued in a timely manner. Support self-inspections/audit related tasks during audit.
• Participate in cross training if required.
• Act as a decision maker while balancing speed, quality, and risk.

Digital Solutions and SharePoint Management:

• Evaluate and recommend electronic solutions to streamline current workflows.
• Establish and manage a SharePoint site to enhance team communication and collaboration.
• Identify and implement digital solutions to replace paper-based processes or enhance existing processes.

Quality and Compliance:

• Perform quality investigations, including root cause analysis, actions/proactive initiatives, and ensure timely completion of investigations.
• Ensure compliance with GxP documentation and data integrity principles in daily work.

Continuous Improvement:

• Propose and support digital solutions to improve process efficiency.
• Create end-to-end workflows and job aids for assigned processes.

• BA/BS degree with 5+ years' experience with Training Management (i.e SuccessFactors, Compliance wire, etc) and QMS Documentation Systems (i.e., CDMS, EDMS, Veeva etc) or MS degree with 3+ years of experience.
• Advanced Knowledge of Microsoft Office (Word, Excel, SharePoint etc)
• Experience in Deviation/Investigation writing, Change Controls, etc Excellent attention to details with ability to work accurately and independently in a busy demanding environment.
• Strong collaboration and communication skills. Ability to successfully work within strict timelines showcasing excellent organizational and time management skills. Ability to negotiate and act as a mediator between functional areas while meeting timeline and pay attention to details.
• Experience using AI tools for process improvement is considered an asset.

The starting compensation for this job is a range from $96,940 - $117,500, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection, and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Years holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder, and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 a supportive culture, promoting global participation 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 BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles, the ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

If you live in