Senior Manager Technical Operations, Global QMS Programs (R1549809-en-us-1)
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.
- This position will support Global Quality in the management of critical data elements, platform integrations, and ensure adherence to Computer System Validation requirements within BMS’s electronic Quality Management System (QMS) called Infinity and will lead the development and management of QMS processes to ensure the system data is accurate and contemporaneous across the following workflows: Change Management, Investigations, Complaints, Audits, CAPAs, Stand Alone Actions and Notification-To-Management.· Reviews Veeva release updates, new functionality and system improvements to determine impact to end users and take appropriate action to prepare users for changes including leading the updating of training materials and procedures· Responsible for identifying negative trends and take appropriate action to resolve issues including escalation, troubleshooting and prioritization· Responsible for the maintenance of policies, SOPs, work instructions, tools, templates and training modules for Infinity processes· Collects and shares best practices through direct communications and communities of practice· Proactively engages and supports end users and encourages user adoption· Act as a business process expert for workflows and system design· Collect system health metrics to identify trends and take appropriate action· Act as subject matter expert and business expert for workflows and system design· Responsible for communication of system status/changes to business users with IT to support user access and account provisioningBASIC QUALIFICATIONS:Bachelor’s degree and 5+ years of Biopharm/Pharmaceutical experirence with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT).PREFERRED QUALIFICATIONS:
- Knowledge of health authority regulations and practical experience applying regulations in change control, investigations, complaints and audits
- Knowledge of compendia, cGxP requirements, FDA regulations and the ability to interpret and apply them
- Proven ability to understand complex processes/problems and propose alternate solutions (required based on need to design and implement global business processes and policies, which requires critical thinking and analysis skills)
- Ability to set priorities and deliver results without constant feedback/input from manager (required based on level of responsibility).
- Ability to identify, manage, and/or escalate issues and risks to timelines
- Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders (required to ensure completeness and robustness of processes and ensures effective adoption of processes)
- Ability to influence, initiate, and manage change
- Organization awareness and ability to work well cross-functionally with R&D, Regulatory Affairs, Global Engineering, etc. (required as these are key stakeholders and partners in the development and implementation of global processes and policies)
- OPEX/Lean Six Sigma experience
- Experience with Veeva Quality Vault
- Strong verbal and written communication skills
- Project management 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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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