Senior Manager, Global Quality GxP Data Integrity SME (R1547636-en-us)
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.
The Data Integrity SME will provide GxP subject matter expertise to support an effective and knowledgeable GxP Data Integrity Governance tower within the Global Quality GxP Data Integrity organization with a focus on remediation activities being performed at the sites and functions. This person will report to the Associate Director of GxP Data Integrity and will also maintain oversight for the management of electronic records and/or electronic signatures in compliance with worldwide health authority regulations.
Provide day to day support for the governance, management, and coordination of activities related to the Data Integrity Governance Program including 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
Responsible for developing, reviewing, and approving appropriate BMS policies and procedures and coordinating all relevant activities between Quality, IT and other departments
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 inspections.
Support and conduct data integrity progress meetings across the network
Develop and utilize metrics and KPIs to assure program success and data integrity remediation progress.
Assist in conducting data integrity gap assessments, developing remediation plans and strategies, and managing tasks to completion.
Ensure compliance with all Company policies and procedures, including safety rules and regulations.
Support the development of standardized tools and training.
Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers.
Support the various audit program across and within departments around data integrity concepts and training.
University Graduate; Life-Sciences degree preferred.
A minimum of 6 years of experience in the pharmaceutical industry along with 4+ years of Data Integrity experience
A minimum of 2 years of experience and in-depth knowledge of GxP computer system validation (CSV) and Part 11 requirements.
Cross-functional experience in three or more areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Pharmacoviligance, Clinical, Regulatory, IT etc.) is desired.
Understanding of clinical systems used for clinical study planning, execution and study closeout. (CTMS, IRT, SaaS, BPaaS)
Understanding of clinical trial process.
Clinical QA Background highly desirable.
Experience with senior level interactions and influence with Manufacturing Operations, Regulatory, R&D, Medical and Clinical functions.
Demonstrate strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.
Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
Excellent interpersonal skills, including written and verbal communication.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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