Bristol Myers Squibb Looking for Sr. Manager, GPS IT CSV and PMO Leader at Hyderabad, Telangana Full Time

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Position Summary

At BMS, digital innovation and Information Technology are central to our vision of transforming patients’ lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care.

GPS IT is seeking a Computer System Validation and PMO Lead to meet evolving and growing needs for IT regulatory Compliance and portfolio management needs across the company’s manufacturing operations. This role would require dual expertise for CSV (Computer System Validation) and skills required to run a PMO. The successful candidate will apply their compliance/validation skills for the validation of GPS IT Systems to directly support BMS’ Global Product Development and Supply Operations. The candidate will also apply their project, program, and portfolio management skills to organize portfolio of projects and bring delivery excellence for the team.

If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

Key Responsibilities

As a CSV Lead:
Lead the Validation team to ensure all aspects of activity within the group adhere to required policies and procedures, including safety and training.

Development of Validation strategy, Validation Master Plans related to computer systems validation for assigned systems.

Develop and review of Computer System Validation Artifacts including Validation Master plans, Requirements Specification, Design Specifications, Test Plans (System Test, User Acceptance Test, Installation Qualification), Test Summary Reports (System Test, User Acceptance Test, Installation Qualification), Traceability Matrix, Validation Summary Report, Release for Use Memo, SOP’s, Work Instructions.

Develops complete understanding of BMS policies and procedures related to all aspects of computer system validation.

Ensure that the validation artifacts meet the quality requirements and applicable regulations FDA (Food and Drug Administration), EU, Corporate & International Standards.

Participate in Validation Cross Functional Teams at corporate and sites (Worldwide) to ensure adherence to required policies and procedures.

Liaises with cross-functional SMEs (Subject Matter Experts) in developing and promulgating the computer system validation methodology.

Pre-approve and post-approve validation documentation and assessments from a quality perspective.

Provides CSV expertise and guidance related to management, peers, and lower-level professionals.

Participate in the Change Management process ensuring that all changes to validated computer systems are effectively assessed to ensure regulatory compliance is always maintained.

Lead the area Validation team in preparation for regulatory, internal, and corporate audits and inspections.

Represent Validation and BMS for audits and any corporate events (as required).

Report out to senior management on Validation status and metrics. Keep abreast of changing regulatory requirements, standards, and guidelines.

As a PMO Lead:
Responsible for assigning and onboarding a PM or PgM to the Project or Program.

Responsible for recruiting PM resources as needed. Fill the gaps during resource transitions.

Responsible for setting expectations and providing oversight on PMs/ PgMs

Responsible for providing guidance and coaching to project teams as appropriate

Manage escalations and proactively communicates to the leadership teams

Proactively communicate portfolio risks and provide appropriate support for timely resolution of risks/issues

• Responsible to bring project to appropriate stage gates (plan, execution, go live) and ensuring PMO lead approvals

Accountable for overall project management activities conducted by project or program managers (Refer PM responsibilities).

Assists in resolving impediments

Ensures transparencies and timely communications (statuses, risks, challenges etc..) to all levels of leadership

Qualifications & Experience

A bachelor’s degree or equivalent experience in computer science, engineering, life science or related field.

Proven track-record of managing a portfolio of large and/or complex IT programs, preferably in the Life Sciences domain. Demonstrated ability to manage multiple, simultaneous projects and programs.

Experience in pharmaceutical industry and an understanding of drug development and manufacturing preferred.

Proven ability to apply depth of expertise across multiple related disciplines and integration points with other functions.

Resolving complex or unusual business problems, typically involving the innovation of new solutions

A strong background in computerized system validation and Manufacturing Execution Systems (MES).

Good technical understanding of IT Infrastructure, manufacturing execution systems (Syncade) and their integration with process automation systems (DeltaV), LIMS (Labware), SAP/Oracle.

Strong knowledge of regulatory validation requirements including FDA, EMA, and all other Worldwide Regulatory requirements.

Relevant experience with data integrity requirements and implementation in a GMP environment.

Knowledge of Quality principles, computer system development lifecycles, QA methodologies, S88 batch control standards and the and ISA-95 manufacturing plant levels.

Knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines and the technical acumen to work and manage within a regulatory environment.

Must have knowledge of Software Development Lifecycle (SDLC) and have working knowledge of the PMI Project Management Body of Knowledge (PMBOK).

Experience with software development methodologies and requirements gathering techniques such as Agile (Scrum, AUP, SAFe etc.) and Waterfall is preferred.

Problem solving ability and excellent oral and written communications skills.

Experience dealing with regulatory agencies and global audit teams.

Excellent communication skills and ability to influence others.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.