Director, Global Biopharmaceutical Stability Operations

Bristol-Myers Squibb-posted 3 months ago

$188,250 - $244,089/Yr

Full-time • Senior

Hybrid • New Brunswick, NJ

Chemical Manufacturing

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The Director, Global Biopharmaceutical Stability Operations drives integration of process and procedures within the Global Biopharmaceutical Stability Group. This position serves to ensure effectiveness and efficiency of the global commercial stability Level 2 process within the QMS framework. This position evaluates and improves upon, and generates, as necessary, trending processes and systems in support of the entire Bristol Myers Squibb commercial product portfolio (biologics & small molecule). This position leads external engagement activity, including support for regulatory surveillance and participating with external communities. Additionally, this position will have team oversight for the implementation and improvement of Data Integrity requirements and Quality Risk Management tools. This position is also accountable for the execution of the commercial stability storage and logistics operations across the entire Bristol Myers Squibb network including management the daily oversight of sample pulls, set downs, documentation and the definition and oversight of our commercial stability storage strategy. This position has oversight of the implementation and management of electronic systems as applied to the Global Biopharmaceutical Stability team, including Laboratory Information Management Systems. This role will combine leadership, collaboration, optimization, global strategy development, and innovative thinking to drive the continuing evolution of the Global Biopharmaceutical Stability team as the Bristol-Myers Squibb Stability Center of Excellence.

Serves 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.
Collaborates with QMS pillar ownership, Level 1 process leads, and network GPOs, Global Process Leads, and Local Process Owners to ensure the QMS as a quality business advantage.
Drives continuing QMS refinement within the commercial Stability Level 2 network toward a more simplified, aligned, and agile global process.
Drives operational excellence initiatives within the Global Biopharmaceutical Stability team and the Global Stability Level 2 network to ensure continuous improvement, innovation, and simplification of QMS processes and procedures to support Quantum Leap.
Leads and oversees assignment and assessment of regulatory surveillance via the External Engagement process and ensures implementation of resulting requirements and guidance.
Oversees the evolution and maturation of the commercialization procedure in order to provide efficient and agile processes to stability product leads for new product and process introductions.
Owns the global Stability Level 2 communities of practice to collaborate and align on a future state process and procedures that will support fit-for-purpose and fit-for-speed execution in context of Quantum Leap.
Manages day-to-day operations of stability sample management, logistics, and enrollment across the Global Biopharmaceutical Stability network, inclusive of internal and external partners, to ensure uninterrupted sample availability and supply in support of commercial stability regulatory requirements.
Oversees and defines the commercial stability storage strategy to generate aligned, harmonized, or standardized operational requirements supporting risk reductions, business continuity, cost effective capacity and resource management, and efficient and compliant storage program strategies.
Ensures all critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply, as a result of events that occur within the logistics areas are escalated as per standard procedures and are resolved within stated timelines (i.e. investigation/deviation and change management procedures).
Dedicates appropriate resources to event management related to logistics storage and enrollment strategies and operations.
Oversees support for the design, development, testing and implementation of IT and business solutions within the Global Biopharmaceutical Stability team.
Ensures appropriate resources are dedicated to product and process changes and events that may have potential impact to program LIMS systems, including: appropriate impact assessments, user requirements, testing, and deployments executed on behalf of the team.
Oversees the implementation of the Global Biopharmaceutical Stability trend program including initial site implementation, periodic review, and the definition and implementation of electronic solutions for the delivery of statistical trend limits.
Leads implementation of a quality risk management program including developing and monitoring quality metrics and ensuring all regulatory requirements are met.
Owns reporting and response against Level 2 and Level 1 metrics to ensure risk reductions, continuing simplification, and event escalation, as appropriate.
Drives definition of yearly and breakthrough objectives to ensure consistency with greater departmental and quality objectives.
Manages Global Biopharmaceutical Stability Book of Work to drive completion of objectives, support resource management across the team, and prioritize efforts for the advancement of the Stability Center of Excellence.
Provides management and coaching to direct reports to generate high performance in the execution of sample logistics and stability LIMS management.
Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors.
Provide continuing development opportunities, including ongoing Performance Connections reviews.
Manages and controls departmental spending for the Global Biopharmaceutical Stability team establishing year-over-year budget strategies for the team.
Makes effective financial and operational decisions to positively impact both short and long-term business objectives.
Accountable for stability resources definition and budget to ensure adherence to cost allowances throughout the year.
Lead efforts to quantify and communicate value capture when efficiencies are put in place.
Works in partnership with site EHS to ensure Stability operations comply with environmental and safety regulatory standards.
Maintains a safe work environment by ensuring that department personnel follow site EHS policies and procedures.

Bachelor's degree and 15+ years of experience required, preferably in chemistry, microbiology, pharmacy, or other related science discipline.
Master's degree and 10 years of experience in leadership role highly desirable.
Strong understanding of cGMPs and regulatory requirements impacting stability programs, non-clinical statistical analysis, and laboratory information management systems.
Understanding of technical areas related to pharmaceutical manufacturing/packaging/distribution, chemical and microbiological analyses, statistical methods, and equipment qualification/calibration.
Must have demonstrated ability to plan, implement, and achieve significant, complex goals and objectives.
Basic understanding of financial management systems used for budget processes.
Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents.
A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.
Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles.
Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions.
Significant experience on health authorities' inspections in front room.
Excellent written and verbal communication skills.
Experience as team manager: planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g., TrackWise or Veeva), Statistics software (e.g., SlimSTAT, JMP, Minitab).

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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