At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Purpose and Scope of Position
The BMS site of Boudry is a Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for projects and New Product Introductions relying on flexible manufacturing and testing operations. The Manager – Quality Projects and Vendors will join the Quality Operations team of BMS, Boudry, Switzerland.
He/She will represent Quality in Supplier/Material/Vendor/Contract Service Provider Management activities. He/She will provide Quality oversight for the routine processes as well as for projects & New Product Introductions. This position will be key to provide the agility necessary to welcome New Products in the Boudry Center of Excellence for product late-stage development and launch, while maintaining routine activities for commercial products. He/She will be the voice of BMS processes and will develop for each project the appropriate strategies related to suppliers for the New Products.
The core mission is to ensure all quality aspects of Supplier/Material/Vendor/CSP activities are efficiently and timely managed in compliance with BMS Global Processes and Policies, Standard Operating Procedures, and GMP requirements & regulations.
It is also expected from the position holder to contribute to the continuous improvement mindset within the quality organization by proposing and implementing improvements.
This position is located at BMS Boudry site.
Required Competencies: Knowledge, Skills, and Abilities
At least 3 years’ experience in Quality Assurance and/or Quality Operations in a pharmaceutical/biotechnological manufacturing and testing site.
Demonstrated experience in Supplier Quality, ideally both as contract giver and acceptor.
Thorough understanding of cGMPs, and EMA, Swissmedic, and FDA regulatory requirements.
Knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches.
Knowledge in project management.
Demonstrated ability to build relationships and foster team cohesion.
Good management, negotiation and decision skills.
At ease to work in a matrix environment.
Proactive, strong ability to adapt rapidly to changes.
Effective communication skill and organizational skills.
Fluency in French and English.
Experience in Lean Manufacturing culture and visual management, is a plus.
Duties and Responsibilities
Quality Projects and Vendors
Ensure deployment and implementation of BMS global processes for Vendor management and Material qualification in Boudry site.
Act as Vendor Quality representative in New Product Introduction projects and work on strategy definition for new excipients/packaging materials, new suppliers and new CSPs.
Lead qualification process of all suppliers/vendors/CSPs and ensure their compliance with standards and expectations.
Lead Quality Agreements management as contract giver and acceptor: ensure quality agreements are issued & maintained and that they are appropriately reflected in procedures and processes.
Lead the day-to-day supplier quality processes in close collaboration with Procurement, Operations, Quality, Supply Chain and SMEs
Lead supplier quality escalation in close collaboration with involved stakeholder and ensure timely and successful closure
Perform on-site supplier visits, if needed, for root cause analysis and verification of CAPAs implementation
Ensure Supplier CAPA are monitored and closed according to defined targets
Handle and assess deviations
Participate to SNC process
Conduct assessment of or act as owner for change controls related to materials/suppliers
Support product complaint investigations
Monitor KPIs and evaluate the overall quality performance of the suppliers and drive improvement actions where necessary
Support selection of new suppliers with Procurement, PMO and MS&T teams (product/material specifications, defect library, satellite samples, quality agreements, etc…).
Drive special quality/supplier management projects, as required.
Act as the Quality Operations representative, i.e QA, QC, compliance, and systems, within the NPI project teams by leading all of the quality aspects.
Monitor best practices both internally and externally, through comprehensive benchmarking, define the implementation strategies and roll out.
Participate actively to inspections / audits site readiness.
Promote continuous improvement in day-to-day activities.
Contribute to CI initiatives, such as improvements, cost/time saving initiatives and sustainability projects.
Ensure compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility and ensures
Work closely with EHS to evaluate hazards and perform risk analysis
Promote safe practices and behaviors, verify that EHS rules are implemented and respected
Definitions and Abbreviations
(c)GMP (Current) Good Manufacturing Practices
CAPA Corrective Action / Preventive Action
CI Continuous Improvement
CSP Contract Service Provider
EHS Environment, Health and Safety
EMA European Medicines Agency
FDA Food and Drug Administration
GIM Global Internal Manufacturing
KPI Key Performance Indicator
MS&T Manufacturing Sciences & Technology
NPI New Product Introduction
PMO Project management office
SME Subject Matter Expert
SNC Supplier Notification of Change
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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