Manager IT Quality Management Qualification Operations

Profile

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.

Manages key strategic initiatives and optimizes the IT Infrastructure qualification process to mitigate risk. Applies IT governance and GAMP knowledge, in collaboration with Global Quality Assurance, to ensure IT Qualification requirements are regularly assessed, consistently met, documented and compliant with external regulations and internal procedures (for servers, databases, storage and applications/software). Facilitates Infrastructure-related inspection and audit requests. Coordinates responses from BMS Hosting, Network, Cyber and User Experience staff, as well as Enterprise Service Providers (ESPs) (DXC, BT and ACCN). Timely follow-up with owners of audit and inspection remediation actions, and CAPAs, is necessary to ensure closure by the agreed upon dates. Performs and documents Problem Management/CAPA quality impact and risk assessments, as required for various Infrastructure tools and services, through collaboration and input from the IT Business owner, DCM and Global Quality Assurance. Works closely with Frameworks-Controls-Monitoring team to ensure Infrastructure-related BMS and ESP operational activities align to IT Controls. Re-evaluates as IT Controls mature/evolve. Makes innovative recommendations for improving efficiency and effectiveness of Infrastructure Qualification. Drives continuous improvement and automation without introducing risk. Works with the IT QM Data Integrity lead to ensure ESPs implement operational activities in alignment with the Data Integrity Program with internal expectations and relevant governmental regulations and guidelines.

Responsibilities:

Ensure IT Qualification requirements are assessed and documented, as well as compliant with external regulations and internal procedures

Provide audit and inspection (and pre-inspection) response support for infrastructure related requests -facilitate responses from BMS and ESPs related to infrastructure processes and services, liaison with quality stakeholders on response

Provide input to resulting CAPAs for IT inspection findings, input to resulting audit remediation observations and management attention comments

Follow up on CAPA and audit remediation deliverables, review/provide evidence for closure

Collaborate and lead cross-functionally to help drive qualification strategy and execution

Execute and maintain documentation for qualification of components and applications/software

Work with peers, BMS IT and ESPs to define and expand controls to align to DI principles

Collaborate with peers across BMS on procedures relating to quality, qualification and computer system validation

Skills & Requirements:

B.S. or equivalent in computer science, engineering, life science or related field

8 years’ experience to include IT Quality, Service Management, and/or relevant experiences

Strong knowledge and experience with ITIL, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines is essential for this position

Candidate must be flexible to support unplanned audit and inspection requests

Demonstrated ability to develop and deliver quality risk assessments and CAPAs

In-depth knowledge of IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases and software tools

Technically conversant in concepts and techniques related to servers, databases & storage devices

Demonstrate the ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives

Demonstrate leadership capability with ability to make and act on decisions while balancing speed, quality and risk

Demonstrated ability to influence, collaborate, and communicate directly at various organizational levels

Strong oral and written communication skills including the ability to write superior documentation and deliver clear and articulate presentations

Open to creative, innovative, flexible and practical approaches to improving practices and solving problem

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com