Manager - Global Quality GxP Data Integrity SME

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.

Principal Objective of the Position

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. Accountable to help 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. Additionally, may support oversight for the management of electronic records and/or electronic signatures in compliance with worldwide health authority regulations.

Key Responsibilities and Major Duties


In conjunction and at the direction of the Associate Director of the GxP Data Integrity Program, 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 in alignment with relevant governmental regulations and guidelines.

Responsible 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.

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.


General Activities


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.

Adherence to BMS core behaviors.


Meeting Participation


GQ GxP Data Integrity Community of Practice meetings

GQ GxP-DI departmental meetings

Interface meetings with site and functional areas supported

Departmental meetings and senior management meetings

IT Quality and Compliance Council


(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Key Stakeholders/Contacts


Members of GQ GxP DI department

Members of the GQ GxP ITQA Quality and eCompliance and department management

Direct (as needed) or contracted reports

Management and staff from the GPS and R&D departments involved in GxP regulated operations (sites/functions)

IT Quality Management Services

Validation Services

Service and Provider Quality Management

Contracted Enterprise Service partners.





Management and staff directly responsible for the business operations of computerized systems

Information Technology staff at commensurate levels of the organizations

Management of the associated quality departments

Inspectors during the conduct of health authority inspections


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

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