Sr. Manager - Global Quality GxP Data Integrity SME
Bristol Myers Squibb
5 hours ago
Remote friendly (New Brunswick, NJ)
United States
Operations
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, focused on remediation activities at sites and functions. Establish and maintain an end-to-end (PDS and R&D) Data Integrity Governance program to ensure regulatory and BMS requirements are addressed thoroughly and effectively. May support oversight for electronic records and/or electronic signatures management in compliance with worldwide health authority regulations.
Key Responsibilities and Major Duties
- Provide day-to-day governance, management, and coordination for the Data Integrity & Data Governance Program, implementing and maintaining Data Integrity compliance across the end-to-end product lifecycle (GPS and R&D) and across BMS sites and internal functions.
- Develop, review, and approve BMS policies and procedures; coordinate activities between Quality, IT, and other departments for implementation, maintenance, and change management of assigned programs.
- Support and manage remediation efforts across the network using QRM principles to identify risk and prioritize.
- Provide active support during regulatory agency and third-party inspections.
- Support and conduct data integrity progress meetings across the network, including assessments and remediations as applicable.
General Activities
- Develop and utilize metrics and KPIs to ensure program success and maturity.
- Conduct data integrity maturity assessments; develop remediation plans and strategies; manage tasks to completion.
- Support foundational Data Governance for quality-critical data (data ownership, standards, quality expectations, and performance metrics).
- Provide subject matter input to reinforce and sustain Data Integrity expectations across the data lifecycle, including governance integration into digital/analytics initiatives impacting GxP data.
- Review and interpret R&D Quality data to identify trends and improvement opportunities; partner to deliver actionable KPIs and dashboards.
- Improve Data Integrity processes/oversight using advanced analytics and AI-enabled tools to enhance risk identification, trend detection, and consistency.
- Ensure compliance with company policies and procedures, including safety rules and regulations.
- Support development of standardized tools and training; benchmark within/outside the company (including regulatory agencies, business partners, suppliers); support audit programs and adherence to BMS core behaviors.
Experience Requirements
- Minimum 6 years of pharmaceutical industry experience.
- Minimum 4 years with in-depth knowledge of Data Integrity requirements.
- Minimum 3 years with in-depth knowledge of GxP computer system validation (CSV) and Part 11 requirements.
Degree Requirements
- University graduate; Life-Sciences degree preferred.
Compensation/Benefits (as stated)
- New Brunswick, NJ, US: $142,040 - $172,113 (starting range for full-time employees). Additional incentive cash/stock may be available (eligibility-based).
Benefits include health coverage; wellbeing support programs; financial protection (e.g., 401(k), disability, life insurance, etc.); and paid time off (including flexible time off and national holidays; plus other eligibility-based time off such as Global Shutdown).
Provide GxP subject matter expertise to support an effective and knowledgeable GxP Data Integrity Governance tower within the Global Quality GxP Data Integrity organization, focused on remediation activities at sites and functions. Establish and maintain an end-to-end (PDS and R&D) Data Integrity Governance program to ensure regulatory and BMS requirements are addressed thoroughly and effectively. May support oversight for electronic records and/or electronic signatures management in compliance with worldwide health authority regulations.
Key Responsibilities and Major Duties
- Provide day-to-day governance, management, and coordination for the Data Integrity & Data Governance Program, implementing and maintaining Data Integrity compliance across the end-to-end product lifecycle (GPS and R&D) and across BMS sites and internal functions.
- Develop, review, and approve BMS policies and procedures; coordinate activities between Quality, IT, and other departments for implementation, maintenance, and change management of assigned programs.
- Support and manage remediation efforts across the network using QRM principles to identify risk and prioritize.
- Provide active support during regulatory agency and third-party inspections.
- Support and conduct data integrity progress meetings across the network, including assessments and remediations as applicable.
General Activities
- Develop and utilize metrics and KPIs to ensure program success and maturity.
- Conduct data integrity maturity assessments; develop remediation plans and strategies; manage tasks to completion.
- Support foundational Data Governance for quality-critical data (data ownership, standards, quality expectations, and performance metrics).
- Provide subject matter input to reinforce and sustain Data Integrity expectations across the data lifecycle, including governance integration into digital/analytics initiatives impacting GxP data.
- Review and interpret R&D Quality data to identify trends and improvement opportunities; partner to deliver actionable KPIs and dashboards.
- Improve Data Integrity processes/oversight using advanced analytics and AI-enabled tools to enhance risk identification, trend detection, and consistency.
- Ensure compliance with company policies and procedures, including safety rules and regulations.
- Support development of standardized tools and training; benchmark within/outside the company (including regulatory agencies, business partners, suppliers); support audit programs and adherence to BMS core behaviors.
Experience Requirements
- Minimum 6 years of pharmaceutical industry experience.
- Minimum 4 years with in-depth knowledge of Data Integrity requirements.
- Minimum 3 years with in-depth knowledge of GxP computer system validation (CSV) and Part 11 requirements.
Degree Requirements
- University graduate; Life-Sciences degree preferred.
Compensation/Benefits (as stated)
- New Brunswick, NJ, US: $142,040 - $172,113 (starting range for full-time employees). Additional incentive cash/stock may be available (eligibility-based).
Benefits include health coverage; wellbeing support programs; financial protection (e.g., 401(k), disability, life insurance, etc.); and paid time off (including flexible time off and national holidays; plus other eligibility-based time off such as Global Shutdown).