Sr Manager, Cell Therapy Quality ERP SME
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb’s Cell Therapy business is entering an exciting new phase as it begins the commercialization of its first CAR-T products. Commercialization drives new scope, scale, and complexity across the network, and drives the need to work together in new ways.
This job is part of the Cell Therapy Quality Systems organization. The Subject Matter Expert (SME) for Cell Therapy Quality ERP will report to the Quality ERP Business Process Owner. This team is responsible for the organization, management and delivery of documentation required for deployment of enhancements to ERP system(s), as well as collaborate with other Quality Systems that may integrate into ERP. The SME will focus on Oracle ERP and work directly with Quality stakeholders at multiple locations, IT SMEs, and other delivery resources to document business use cases, user requirements, test scripts, reports, and trace matrices to support scalable and compliant delivery of business capabilities within ERP system(s).
This job reports in through Bristol Myers Squibb’s Cell Therapy Quality Systems and works closely with Cell Therapy Business Process Management, Cell Therapy subject matter experts, and IT partners. This is an exciting opportunity to shape how BMS’s Cell Therapy manufacturing network operates and be part of a team influencing the overall future of the Cell Therapy network.
- Work cross-functionally with various business and IT functions to support Cell Therapy Quality.
- Maintain subject matter expertise in delivery support processes including, but not limited to: GxP and IT controlled documentation management processes and systems; GxP and IT change management processes and systems; and business and IT process management, requirement management, and business testing management processes and systems.
- Responsible for performing impact assessments when new enhancements are requested, as well as documenting the assessment within applicable change control.
- Document detailed business processes and business requirements by working with Quality stakeholders at manufacturing and product release sites.
- Responsible for writing and dry-running test scripts for quality functionality in ERP test environments.
- Execute user acceptance test (UAT) on behalf of business, as assigned.
- Support development of training content by providing screen recordings, business process flows, business context (why and when a user would perform the transaction).
- Work with site Quality teams to assist in review and approval of site master data, as needed
- Provide review of training content; assist in training site trainers of new enhancements to ensure Quality customers are receiving training within a timely manner.
Qualifications and Education Requirements
- Bachelor's degree in a life sciences or engineering discipline, or a minimum of 7-10 years of relevant biotechnology or pharmaceutical industry. Pharmaceutical manufacturing experience is strongly preferred.
- 5+ years of direct experience involved with Quality Systems
- Experience with ERP applications; Oracle and SAP
- Demonstrated ability to influence at all levels within the organization
- Experience with managing controlled documentation, preferably within a regulated industry
- Experience working with IT deliverables, such as requirements and testing documentation
- Ability to work independently and cooperatively in a diverse group.
- Ability to provide leadership, guidance and coaching to members of the organization.
- Excellent oral and written communication skills.
- Proven record leading or contributing to projects or programs in support of GXP operations
- Extensive knowledge of current industry practices
- Experience with interpretation and application of guidelines and regulations
- Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
- Preferred experience with requirements and/or testing management tools such as HP ALM.
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.
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