Senior Manager, QMS Systems

Posted 29 days ago
Main Location
New York City, NY, United States
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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.

Purpose and Scope of Position:

The Manager, Quality Assurance Methods/ Quality Systems – will be responsible for managing integration activities related to EQRMS CAPA & Deviation systems along with runout of existing system. In this role, the incumbent will serve as business process owner for the eQRMS electronic CAPA and Deviation modules, the associated governing procedures and supporting processes. This is a highly visible role with global responsibility and cross-functional influence that has an impact on departmental performance and broad quality initiatives requiring both strategic and tactical decision making. In this capacity, the Manager will be the primary subject matter expert for GMP CAPA and Deviations across the company. This position will transition into system support for Infinity implementations of Quality Risk Management and electronic document management systems in Veeva

Required Competencies:  Knowledge, Skills, and Abilities

  • Must have expert GMP, Quality, and in-depth risk management knowledge, particularly in the areas of CAPA and Deviations.
  • Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Documentum and ComplianceWire.
  • Must complete tasks independently and be confident in making complex decisions in their subject matter area, consulting with supervisor for decisions outside of established processes.
  • Will interact with and influence across multiple departments and sites.
  • Shall perform role of global lead for site leadership teams in the areas of Deviations and CAPA.
  • Must be able to conceptualize broad impact of system related initiatives and recognize quality issues. 
  • Must be a problem solver, actively seeking management guidance on complex issues.
  • Shall be able to effectively prepare communications to the customer and management in a productive manner with clarity, brevity and accuracy.
  • Shall play a role on Quality initiatives and be able to conceptualize broad impact of Quality on sites and/or departments.
  • Must be familiar with the roles and responsibilities of common GMP functional areas such as Quality, Pharmaceutical Development, Regulatory Affairs and CMC, Technical Operations and Manufacturing.
  • Must be action-oriented and customer-focused and skilled in the following areas:
    • Communication
    • Building relationships
    • Problem solving and negotiation
    • Conflict management
    • Analytical thinking
  • Must have a thorough knowledge of PC productivity tools such as Word, Excel, PowerPoint, and Visio.

Duties and Responsibilities:

  • Support the end user community of eQRMS and Celdox and BMS's electronic document management system for all document types and workflows.
  • Function as the Quality System Owner for the CAPA and Deviation systems and all associated processes and procedures.
  • Serve as the subject matter expert for business process and associated electronic system.
  • Plan and implement lifecycle changes and system level enhancements through partnership with IT Developers and Business Analysts.
  • Author and maintain all standards, policies, procedures, work practices and job aides that support the CAPA and Deviation system ensuring all documents and processes comply with applicable regulations, guidance documents and industry best practices.
  • Develop and conduct user training and manage system access.
  • Execute the transition of Dev/CAPA users into the Infinity QMS Platform.
  • Own and provide oversight metrics to support system use runout.
  • Represent CAPA & Deviation as subject matter expert and process owner in a front-room capacity during all internal and third party audits/inspections.
  • Create and distribute all metrics, analytics and performance indicators for CAPA and Deviation inclusive of system runout metrics
  • Collaborate with cross-functional system partners and represent the CAPA and Deviation user community in all governance and life-cycle related capacities.
  • Own and implement a consistent and effective document hierarchy plan for CAPA and Deviation, including local and global elements.
  • Provide cross-functional support to other Quality Management systems
  • Support system implementation of electronic Document Management
  • Support system implementation of Quality Risk Management

Education and Experience:

  • Relevant college or university degree in a scientific and/or clinical area of study preferred.
  • Minimum 7 years relevant work experience and minimum 3 years of leadership experience; equivalent combination of education and experience acceptable.

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. 

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 any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

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Senior Manager, QMS Systems
Bristol Myers Squibb