Sr. Manager - Global Quality GxP Data Integrity SME

Working with Us
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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 for helping establish and maintain an end-to-end (PDS 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 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 & Data 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.

• Support and conduct data integrity progress meetings across the network. This may include leading/supporting specific site- or organizational-group data integrity assessments and remediations, as applicable.

General Activities

• Develop and utilize metrics and KPIs to ensure program success and maturity.

• Assist in conducting data integrity maturity assessments, developing remediation plans and strategies, and managing tasks to completion.

• Support foundational Data Governance activities for quality critical data, including identification of data ownership, standards, quality expectations, and performance metrics, in alignment with Global Quality priorities.

• Provide subject matter input to ensure Data Governance practices reinforce and sustain Data Integrity expectations across the data lifecycle, including integration of governance considerations into digital and analytics initiatives impacting GxP data.

• Enable data‑driven insights by reviewing and interpreting R&D Quality data, identifying trends and improvement opportunities, and partnering with RDQ pillars and BI&T to deliver clear, actionable KPIs and dashboards that drive visibility, accountability, and action.

• Identify and support opportunities to improve Data Integrity processes and oversight through responsible use of advanced analytics and AI‑enabled tools, enhancing risk identification, trend detection, and consistency.

  • Ensure compliance with all Company policies and procedures, including safety rules and regulations.

  • Support the development of standardized tools and training.

  • Benchmarks within and outside of the Company, including regulatory agencies, business partners, and suppliers.

  • Support the various audit programs across and within departments around data integrity concepts and training.

  • Adherence to BMS core be