Associate Director, Data Integrity - Program Lead

Working with UsChallenging. 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 Responsibilities and Major Duties:Establish, lead and manage an effective and knowledgeable GxP Data Integrity Program Governance tower within the Global Quality GxP Data Integrity organization and accountable to establish and maintain an end-to-end (GPS and R&D) Data Integrity Governance program to ensure that regulatory and BMS requirements are addressed thoroughly and effectively in a timely manner.  Integration of the key DI metrics/risk indicators within Tier council infrastructure.Key Responsibilities and Major Duties:In conjunction and at the direction of the Head of the GxP Data Integrity Program, provide day to day oversight for the governance, management and coordination of activities related to the Data Integrity Governance Program include implementing and maintaining Data Integrity compliance activities across the end-to-end product lifecycle (GPS and R&D) and across all BMS sites and internal functions in alignment with relevant governmental regulations and guidelines.Responsible to drive Data Integrity process design / optimization activities following standard methodology.Responsible to sustain and drive continuous improvement post-implementation of the DI FrameworkResponsible for developing, reviewing, and approving appropriate BMS policies and procedures and coordinating all relevant activities between Quality, IT and other departments in relation to implementation, maintenance and change management of assigned programs.Develop and deploy data integrity training – internal/external facingProvide adjunct oversight of regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.Support and manage remediation efforts across the network, utilizing QRM based principles to identify risk and establish appropriate prioritization.Provide active support during regulatory agency and third party inspectionsOversees the GxP Data Integrity Community of PracticeDevelops and manages metrics and scorecards for DI program healthOversees and monitors the progress of the Data Integrity Master Plan (DIMP) across the sites and functionsDevelops & implements the communication strategy for DIGeneral Activities:Develop and utilize metrics and KPIs to assure programs’ successEnsure compliance with all Company policies and procedures, including safety rules and regulationsBenchmark within and outside of the Company, including regulatory agencies, business partners and suppliersSupport regulatory inspections and the various audit programs across and within departments around data integrity expectationsLead GQ GxP Data Integrity Community of Practice meetings as well as attend GQ GxP Data Integrity departmental meetings and IT Quality and Compliance CouncilResponsible for interacting with Head of the GQ GxP ITQA organization, other members of GQ GxP-DI and RCEE and department management, Management and staff from the GPS and R&D departments involved in GxP regulated operations, IT Quality Management Services, and Inspectors during the conduct of health authority inspectionsDegree & Experience Requirements:B.S in science, engineering, biochemistry or related discipline, or its equivalent is highly desired, life Sciences preferredA minimum of 3 years’ experience and in-depth knowledge of Data Integrity requirementsA minimum of 6 years’ experience and in-depth knowledge of GMP computer validation, and Part 11 requirementsProven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures (minimum 4 years’ experience).Good Understanding of Quality Risk Management PrinciplesKey Competency Requirements:Bio-tech/pharmaceutical/GMP industry or experience in a highly regulated environment strongly preferred ·Extensive knowledge of SOPs and GxPs and the know-how to work and manage within a regulated environment ·Strong change management skills and demonstrated ability to simplify and improve business processes ·Excellent leadership skills with the ability to motivate and manage a team with matrix reporting relationships ·Adaptable to a fast paced, complex and ever-changing business environmentEffective verbal and written communications skills ·Excellent verbal communication, documentation and technical writing skills ·Demonstrated creative problem-solving skills under resource constraints and time pressureAbility to demonstrate strong project management focus as well as focus on execution of strategic decisions while balance conflicting prioritiesMust understand industry accepted software development and validation life cycle programs.Strong sense of ethics, diplomacy and discretion.Commitment to Quality.Strong critical thinking to analyze complex situations and discern critical issues.Able to work effectively with multicultural workforce.Up to 20% Travel may be required#LI-HybridIf 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 CareersWith 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 ProtocolPhysical 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.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.