Manager, Global Quality Electronic System and Programs
About the Job
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
Among our several NJ locations, our Hopewell and Bloomsbury sites are key components of the Biologics Network Strategy, with available Process Development and Analytical Development & Testing opportunities to support the innovating biologics under development.
- Managing and coordinating activities related to cGMP Enterprise Electronic Systems.
- Duties include leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GMS applications.
- Responsible for developing policies and procedures and coordinating all activities relevant between the Quality departments, IT validation and information technology in relation to implementation, maintenance and change control of computerized systems.
- A key focus of this role will be to provide quality/compliance oversight to all computer system validation related activities across the GMS enterprise.
- The manager will guide the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements.
- Provide oversight and direct support during inspections as it relates to computer system validation and associated processes.
- Ensure the necessary documents are reviewed as per policies and procedures.
- This role will also provide support services and governance to all supporting IT areas (GMS corporate and sites) to ensure global alignment to the computer compliance, global validation and change control standards.
- The manager will serve as a business and/or process owner for one or more of the following IT systems\: TrackWise, EtQ, Document Management System, SAP-QM, Success Factors, and others as assigned.
- Responsibilities also include providing support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.
- 21CFR11/ EU GMP Annex 11 and GAMP 5 standards
- Data Integrity Guidance
- Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
- Project management practices and techniques
- Software development life cycle
- In depth knowledge of one or more of the following IT systems\: TrackWise, EtQ(or equivalent), SAP-QM, laboratory systems (such as LIMS, Empower, Sample manager, Instrumentation), manufacturing execution systems (such as Syncade), others as applicable to GPS IT systems scope
- Pharmaceutical principles, practices and applications
- Computer hardware and software applications including Quality related computer systems, MS Office and MS Project
- Principles and practices of computer compliance, validation and qualification
- Knowledge of automated testing practices and tools a plus
- External and internal inspections
- Stakeholder management in a cross-functional organization
- Reviewing user, functional and design specifications.
- Reviewing and executing protocols and test scripts
- Sampling, testing and measuring techniques.
- Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
- Selecting, training, supervising and evaluating departmental personnel
- Managing multiple projects, duties and tasks,
- Communicating clearly and concisely, both orally and in writing.
- Establishing and maintaining effective working relationships with those contacted in the course of work.