Bristol Myers Squibb
Director, Global Biopharmaceutical Stability Operations
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Overview
Director, Global Biopharmaceutical Stability Operations. Join to apply for the Director, Global Biopharmaceutical Stability Operations role at Bristol Myers Squibb. Working with Us: Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers opportunities for growth and impact across departments, with a focus on transforming patients’ lives through science. Position Summary: The Director, Global Biopharmaceutical Stability Operations drives the integration of processes and procedures within the Global Biopharmaceutical Stability Group. This role ensures the effectiveness and efficiency of the global commercial Stability Level 2 process within the QMS framework, supporting the entire Bristol Myers Squibb commercial product portfolio (biologics & small molecules). It leads external engagement, regulatory surveillance, and provides team oversight for Data Integrity and Quality Risk Management tools. The role also oversees commercial stability storage and logistics operations across the network, including daily sample pulls, set downs, documentation, and the storage strategy. It includes responsibility for electronic systems (e.g., LIMS) and collaboration across global teams to evolve the Stability Center of Excellence." Key Responsibilities
Serve as the commercial stability Global Process Owner (GPO) providing leadership for program governance, operations, escalations, and benefits realization with respect to the QMS and global Stability Level 2 processes and systems. Collaborate with QMS pillar ownership, Level 1 process leads, and network GPOs to ensure the QMS as a quality business advantage. Drive continuing QMS refinement within the commercial Stability Level 2 network toward a simplified, aligned, and agile global process. Drive operational excellence initiatives within the Global Biopharmaceutical Stability team to support continuous improvement, innovation, and simplification of QMS processes and procedures. Lead and oversee regulatory surveillance via the External Engagement process and ensure implementation of resulting requirements and guidance. Oversee the evolution of the commercialization procedure to provide efficient and agile processes for stability product leads for new product and process introductions. Own the global Stability Level 2 communities of practice to align on future-state processes and procedures for fit-for-purpose execution. Manage day-to-day stability sample management, logistics, and enrollment across the Global Biopharmaceutical Stability network to ensure uninterrupted sample availability and supply. Oversee and define the commercial stability storage strategy to support risk reduction, business continuity, cost-effective capacity, and compliant storage program strategies. Escalate and resolve critical issues in logistics areas within standard procedures and timelines (investigations, deviations, change management). Allocate resources to event management related to logistics storage and enrollment strategies and operations. Oversee IT and business solution design, development, testing, and deployment within the Global Biopharmaceutical Stability team, including LIMS. Ensure resource dedication to product and process changes impacting LIMS, including impact assessments, requirements, testing, and deployments. Implement the Global Biopharmaceutical Stability trend program and electronic solutions for delivering statistical trend limits. Lead a quality risk management program including development and monitoring of quality metrics and regulatory compliance. Own reporting and response against Level 2 and Level 1 metrics to drive risk reduction and escalation as appropriate. Define yearly and breakthrough objectives aligned with departmental and quality goals. Manage Global Biopharmaceutical Stability Book of Work to drive objective completion and resource planning for the Stability Center of Excellence. Provide management and coaching to direct reports to achieve high performance in sample logistics and stability LIMS management. Foster a culture aligned with company values and behaviors. Support ongoing development opportunities, including regular Performance Connections reviews. Manage and control departmental spending and budget planning for the Global Biopharmaceutical Stability team. Make financial and operational decisions to impact short- and long-term objectives; ensure budget adherence. Lead efforts to quantify and communicate value capture from efficiencies realized. Collaborate with site EHS to ensure stability operations comply with environmental and safety regulations; maintain a safe work environment. Qualifications & Experience
Bachelor’s degree and 15+ years of experience required; Master’s degree with 10 years in a leadership role is highly desirable (preferred in chemistry, microbiology, pharmacy, or related sciences). Strong understanding of cGMPs and regulatory requirements impacting stability programs, non-clinical statistical analysis, and LIMS. Knowledge of pharmaceutical manufacturing/packaging/distribution, analytical methods, statistics, and equipment qualification/calibration. Proven ability to plan and achieve complex goals; basic understanding of financial management for budgeting. Expert knowledge of stability ICH Guidelines (Q1A, Q5C) and cGMP regulations (21 CFR) as applied to stability programs. Strong knowledge of US/EU/ROW regulatory requirements and industry best practices; experience with Drug Substance/Product manufacturing and analytical/microbiology methods. Experience authoring investigations and applying quality management principles; ability to drive science-based decision making. Experience with health authority inspections; excellent written and verbal communication skills. Experience as a people manager with skills in planning, coaching, conflict management, and resource allocation. Advanced knowledge of Microsoft Office, LIMS, Quality Management systems (e.g., TrackWise or Veeva), and statistics software (e.g., JMP, Minitab). Basic understanding of financial management systems for budgeting. Compensation & Benefits
The compensation overview includes regional ranges. The starting compensation range is provided for full-time roles, with potential incentive cash and stock opportunities based on eligibility. Final pay is determined based on experience. Benefits vary by location and may include medical, dental, vision, 401(k), life insurance, disability, and other programs. Details and eligibility are described on the company careers site. On-site Protocol & Equal Opportunity
BMS has an occupancy structure that determines where an employee is required to work (site-essential, site-by-design, field-based, remote-by-design). Site-essential roles require 100% onsite, site-by-design roles may allow hybrid work with at least 50% onsite, and field/remote roles require travel as an essential function. BMS provides accommodations for applicants with disabilities and does not discriminate in its recruitment, as described in its Equal Employment Opportunity statement. For accommodation requests, contact adastaffingsupport@bms.com and visit careers.bms.com/eeo-accessibility for more information. Vaccination guidance is provided, and legal references apply to local requirements. For California residents, see the California-residents page for additional information. Data collected during applications is processed per applicable privacy policies. Seniority level
Director Employment type
Full-time Job function
Business Development and Sales Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Director, Global Biopharmaceutical Stability Operations. Join to apply for the Director, Global Biopharmaceutical Stability Operations role at Bristol Myers Squibb. Working with Us: Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers opportunities for growth and impact across departments, with a focus on transforming patients’ lives through science. Position Summary: The Director, Global Biopharmaceutical Stability Operations drives the integration of processes and procedures within the Global Biopharmaceutical Stability Group. This role ensures the effectiveness and efficiency of the global commercial Stability Level 2 process within the QMS framework, supporting the entire Bristol Myers Squibb commercial product portfolio (biologics & small molecules). It leads external engagement, regulatory surveillance, and provides team oversight for Data Integrity and Quality Risk Management tools. The role also oversees commercial stability storage and logistics operations across the network, including daily sample pulls, set downs, documentation, and the storage strategy. It includes responsibility for electronic systems (e.g., LIMS) and collaboration across global teams to evolve the Stability Center of Excellence." Key Responsibilities
Serve as the commercial stability Global Process Owner (GPO) providing leadership for program governance, operations, escalations, and benefits realization with respect to the QMS and global Stability Level 2 processes and systems. Collaborate with QMS pillar ownership, Level 1 process leads, and network GPOs to ensure the QMS as a quality business advantage. Drive continuing QMS refinement within the commercial Stability Level 2 network toward a simplified, aligned, and agile global process. Drive operational excellence initiatives within the Global Biopharmaceutical Stability team to support continuous improvement, innovation, and simplification of QMS processes and procedures. Lead and oversee regulatory surveillance via the External Engagement process and ensure implementation of resulting requirements and guidance. Oversee the evolution of the commercialization procedure to provide efficient and agile processes for stability product leads for new product and process introductions. Own the global Stability Level 2 communities of practice to align on future-state processes and procedures for fit-for-purpose execution. Manage day-to-day stability sample management, logistics, and enrollment across the Global Biopharmaceutical Stability network to ensure uninterrupted sample availability and supply. Oversee and define the commercial stability storage strategy to support risk reduction, business continuity, cost-effective capacity, and compliant storage program strategies. Escalate and resolve critical issues in logistics areas within standard procedures and timelines (investigations, deviations, change management). Allocate resources to event management related to logistics storage and enrollment strategies and operations. Oversee IT and business solution design, development, testing, and deployment within the Global Biopharmaceutical Stability team, including LIMS. Ensure resource dedication to product and process changes impacting LIMS, including impact assessments, requirements, testing, and deployments. Implement the Global Biopharmaceutical Stability trend program and electronic solutions for delivering statistical trend limits. Lead a quality risk management program including development and monitoring of quality metrics and regulatory compliance. Own reporting and response against Level 2 and Level 1 metrics to drive risk reduction and escalation as appropriate. Define yearly and breakthrough objectives aligned with departmental and quality goals. Manage Global Biopharmaceutical Stability Book of Work to drive objective completion and resource planning for the Stability Center of Excellence. Provide management and coaching to direct reports to achieve high performance in sample logistics and stability LIMS management. Foster a culture aligned with company values and behaviors. Support ongoing development opportunities, including regular Performance Connections reviews. Manage and control departmental spending and budget planning for the Global Biopharmaceutical Stability team. Make financial and operational decisions to impact short- and long-term objectives; ensure budget adherence. Lead efforts to quantify and communicate value capture from efficiencies realized. Collaborate with site EHS to ensure stability operations comply with environmental and safety regulations; maintain a safe work environment. Qualifications & Experience
Bachelor’s degree and 15+ years of experience required; Master’s degree with 10 years in a leadership role is highly desirable (preferred in chemistry, microbiology, pharmacy, or related sciences). Strong understanding of cGMPs and regulatory requirements impacting stability programs, non-clinical statistical analysis, and LIMS. Knowledge of pharmaceutical manufacturing/packaging/distribution, analytical methods, statistics, and equipment qualification/calibration. Proven ability to plan and achieve complex goals; basic understanding of financial management for budgeting. Expert knowledge of stability ICH Guidelines (Q1A, Q5C) and cGMP regulations (21 CFR) as applied to stability programs. Strong knowledge of US/EU/ROW regulatory requirements and industry best practices; experience with Drug Substance/Product manufacturing and analytical/microbiology methods. Experience authoring investigations and applying quality management principles; ability to drive science-based decision making. Experience with health authority inspections; excellent written and verbal communication skills. Experience as a people manager with skills in planning, coaching, conflict management, and resource allocation. Advanced knowledge of Microsoft Office, LIMS, Quality Management systems (e.g., TrackWise or Veeva), and statistics software (e.g., JMP, Minitab). Basic understanding of financial management systems for budgeting. Compensation & Benefits
The compensation overview includes regional ranges. The starting compensation range is provided for full-time roles, with potential incentive cash and stock opportunities based on eligibility. Final pay is determined based on experience. Benefits vary by location and may include medical, dental, vision, 401(k), life insurance, disability, and other programs. Details and eligibility are described on the company careers site. On-site Protocol & Equal Opportunity
BMS has an occupancy structure that determines where an employee is required to work (site-essential, site-by-design, field-based, remote-by-design). Site-essential roles require 100% onsite, site-by-design roles may allow hybrid work with at least 50% onsite, and field/remote roles require travel as an essential function. BMS provides accommodations for applicants with disabilities and does not discriminate in its recruitment, as described in its Equal Employment Opportunity statement. For accommodation requests, contact adastaffingsupport@bms.com and visit careers.bms.com/eeo-accessibility for more information. Vaccination guidance is provided, and legal references apply to local requirements. For California residents, see the California-residents page for additional information. Data collected during applications is processed per applicable privacy policies. Seniority level
Director Employment type
Full-time Job function
Business Development and Sales Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr