Global Process Owner CSV

Profile

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.


Serve as Global Process Owner for BMS' Computer System Validation framework across the company developing necessary processes, systems, roles, capabilities and cultural norms required to develop, install and sustain a validated computer system ecosystem to ensure that such systems can consistently and effectively support BMS Sites and functions related to regulated activities.
In strong alignment with IT Quality Assurance team and business, define and establish a consistent approach and process for computer systems validation with the right roles and capabilities to sustain such a program
Collaborating and influencing key stakeholders across IT, R&D, GPS and Medical Affairs, including Sites.
Establishment of such a program ensures BMS moves to a state of demonstrated robust compliance with 21 CFR Part 11 and other regulatory requirements in the GMP, GDP and GCP/PV space thus allowing us to improve GxP Inspectional performance in R&D and GPS.
Matrix leader building and cultivating effective relationships and collaborations spanning Sr. Executive leaders through to shop floor personnel needing to understand and execute the program.
Establish and execute a specific culture plan to embed the right behaviors, mindset and thinking in risk-based thinking in the adoption of technology in the regulated space.
Matrixed reporting into Global Quality and a member of the leadership team under Head of Regulatory Compliance and External Engagement
Build and manage a team of 3 to 5 direct reports at the Director to Associate Director Level.
Establish CSV metrics , using QRM principles to be used by Quality Council network to monitor performance. review and trend at appropriate Quality Councils including the company Tier 1 Quality Council.
Establish and provide risk information and data to the Chief Quality Officer for reporting to the Audit Committee those key risks that must be escalated to the Board and CEO. Requirements:
20 years experience in pharmaceutical industry
Direct operational experience defining and implementing CSV globally for enterprise and local systems across GMP, GCP, PV and/or GLP
Ability to develop and implement frameworks across Sites and functions
Ability to establish strong relationships and influence with senior executive leaders
Insight to industry practices related to CSV as well as emerging regulations to ensure that we can pro-actively respond to meet or exceed regulatory expectations related to CSV.
Serve as the BMS CSV expert to benchmark and continuous improve with peer companies. 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. Company: Bristol-Myers Squibb Req Number: R1525682_EN Updated: 2020-07-08 00:00:00.000 UTC Location: Princeton,New Jersey


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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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