Manager, Global Clinical Supply Chain Compliance Operations

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Position Summary

The Global Clinical Supply Chain Compliance Manager ensures GxP compliance in GCSC by providing QMS operational support and partnering in business activities, while identifying and supporting process improvements.

The role involves managing Global Clinical Supply Chain compliance, monitoring process performance, performing trend analysis and supporting audit/inspection readiness.  The incumbent will proactively identify/report to management operational and systemic compliance issues and/or risks related to clinical supply chain end-to-end processes  
Responsibilities

• Collaborate with GCSC functions to maintain GxP compliance and to support business activities in compliance with procedural requirements.
• Serve as advisor and functional expert as an accepted body of knowledge and experience in area of expertise.
• Collaborate with GSC Global process owners in designing, managing, and improving capabilities.
• Monitor compliance, report performance metrics and perform trend analysis for processes as required.
• Monitor status of CAPAs to ensure GCSC commitments are met; follow-up as required with e-QMS record owners for the timely completion/extension before their due date
• Participates in Clinical Supply Chain Quality Council meeting as Data Steward/Metrics SME
• Own / support eQMS records such as deviations, change controls, CAPAs, pro-active initiatives, stand-alone actions, and risk assessments on behalf of GCSC functions. Perform role of lead investigator for assigned deviation and/or investigational medicinal product quality complaint records as required.
• Lead GCSC personnel in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies and acting as primary CSC point of contact
• Conducts root cause analysis to develop responses to audit and inspection findings
• Collaborate with functional areas to determine best solutions to resolve any identified compliance issues
• Identifies and escalates technical and/or business issues promptly; must be able to have the ability to solve routine issues independently.
• Contributes to the development of procedural documents as needed.
• Support cross-functional/strategic initiatives and continuous improvement projects as assigned
• Exercise sound judgment, using a risk-based approach, to ensure compliance with PD regulations, practices, and policies.
• Contributes to or manage strategic initiatives and continuous improvement projects as assigned.
• Collects and shares best practices through direct communications and communities of practice.
• Maintain a contemporary knowledge of current industry trends, standards, and methodologies as it relates to quality systems and management.

Designee Role and Responsibilities

GCSC Compliance Manager may be delegated responsibility for eQMS activities such as Infinity change owner, deviation owner etc to support GCSC roles for example – Trial Supply Manager

Required Competencies

• Excellent interpersonal skills
• Excellent communication skills
• Technical writing capability
• Good time management and organizational skills
• Ability to multi-task numerous projects
• Ability to work with initiative
• Ability to achieve targets and milestones
• Flexible and motivated
• Data analysis
• Supply Chain Acumen
• Confident public speaker
• Ability to solve routine problems

Required Qualifications and desired experience

Bachelor’s degree in Supply Chain, Engineering, or related Scientific/ Technical discipline

Experience / Knowledge Desired

• More than 5 years in a compliance and/or quality assurance.
• Working knowledge GCP/GDP/ GMP and of e-Quality Management systems (eQMS) e.g. Veeva Vault
• Minimum 3 years’ experience in Clinical Supply Chain Management or related field (ex. Interactive Response Technology (IRT), Drug Development, Clinical Operations, etc.)
• General knowledge of all phases, processes, and functions of drug development.
• General knowledge of investigational material supply chain processes.
• Experience working in a highly regulated environment
• Cross functional collaboration experience developing systems and standard ways of working, digitized metrics and reporting

Travel Requirements

10% Travel

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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