QA Manager - Documentation and Training

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary:

• Ensure compliance within the organization as it pertains to documentation and records management.
• Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. DocMan, PDHQ) and BMS Records Management Systems
• Audit readiness and support
• Metrics generation and communication (i.e. upcoming periodic reviews, schedule for off-site storage and/or destruction)
• Support compliance within the organization as it pertains to training and audit support.
• Provide support as a Content Manager of various PD Electronic Document Management Systems (e.g. ELMS, PDHQ) and BMS Records Management Systems
• Audit readiness and support
• Metrics generation and communication
• Provide support on the implementation and maintenance of the training program and Quality Management systems such as but not limited to Infinity and QUMAS

Responsibilities:

• Utilize the Records Management System to manage hardcopy GMP documents submitted for retention and archival.
• Manage site usage of the records management system.
• Manage procedural documentation, records management, and audit support processes.
• Manage paper Master Batch Record preparation, forms and logbooks/notebooks issuance, tracking and reconciliation for the NBR site.
• Provide third party oversight for notebook/logbook design, print and issuance to BMS.
• Provide overall PD functional area oversight for document control/records management.
• Provide regulatory/inspection and internal audit support.
• Participate in the GPS Learning Community of Practice. Drive change and support alignment and harmonization of "best training practices" across the GPS network.
• Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
• Provides instruction and guidance on quality issues and serves as a resource for the site.
• Serve as administrator of the Electronic Learning Management System (ELMS) and the records management system.
• Manaage training program by conducting supplementary Community of Practice meetings for ELMS administrators, providing oversight on RBCs and training programs within PD for consistency
• Manage the development of training project plans and perform all the necessary activities to support successful implementation.
• Create quizzes for training items utilizing Pedagogue or equivalent software.
• Provide appropriate internal audit/regulatory inspection support relevant to training documentation.
• Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
• Adherence to BMS core behaviors

Professional experience and qualifications:

• B.S. with 4+ years of relevant experience, preferable in a regulated industry
• Experience within a QA environment is required
• Knowledge of ELMS and other Enterprise Systems (i.e. DocMan, PDHQ, SuccessFactors) is highly desirable.
• Familiarity of GMP regulations
• Strong collaborative skills
• Effective written and verbal communication
• Computer literacy: Microsoft Office and other systems as required

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 the resources to pursue their goals, both at work and in their personal lives.