Position: Mid-Senior level

Job type: Full-time

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Job content

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.

The Role

Bristol Myers Squibb is looking to recruit a permanent Senior Manager, Quality Management Systems and Compliance based in Boudry.

The Senior Manager, Quality Management Systems and Compliance supports the application of quality management systems and ensures compliance across the global Supply Chain and In-Market Quality (SCIM) organization and works in close cooperation with stakeholders within the global quality teams.

Key Duties And Responsibilities

Inspections and Regulatory Surveillance (Health Authority (HA) inspections, Global Internal Audits)
  • Represent SCIMQ on cross-functional inspection and regulatory surveillance related initiatives and projects.
  • Representative for Inspection eSystems initiatives for SCIMQ, drive implementation of IT tools and support SCIMQ organization and stakeholders in using the eSystem implemented.
  • Actively support HA inspection and Global Internal Audit readiness in local markets.
  • Provide support during HA Inspections and Global Internal Audits in local markets.
  • Responsible for recording and review and tracking findings from HA inspections.
Data Integrity Management
  • Represent SCIMQ on cross-functional DI related initiatives and projects.
  • Partner with Global Quality Process Owners for DI processes and systems.
  • Support SCIMQ organization and stakeholders in using DI process implemented.
Other QMS and Compliance activities
  • Represent SCIMQ on Fusion projects.
  • Oversight of BMS Quality Management System (QMS) implementation and compliance with GMP/GDP guidelines to the several countries in SCIMQ.
  • Guidance for Implementing and updating content of Shared platform for all SCIMQ.
  • Guidance for Reports/ Metrics on overall quality metrics for Change Control, Deviation, CAPA, NTM, Batch research, Stand-Alone Actions, Findings, and Audit and Inspections.
  • Contribute to the on boarding on QMS& Compliance for new team members across SCIMQ organisation.
  • Ensure capabilities for using of the Infinity electronic QMS and ensure compliance
  • Subject Matter Expertise for various processes, for example Change control Management, Deviation Management, CAPA Management, HA Inspection, Global Internal Audits, Regulatory Surveillance, Data Integrity.
  • Contribute to the QMS process owner network and academy.
  • Partner with Integration Project team participate to meeting and perform actions for integration.
  • Act as Change champion for SCIMQ and share knowledge/ information.
  • Organize, prepare and lead SCIMQ global team meetings.
  • Ad Hoc support for Recalls, Technical Quality Agreements, Annual Product Quality Review, Notification to Management, MAH transfer, regulatory compliance.
  • Strategy participation in continuous improvement initiatives.
  • Act as designee for Director of Quality System and Compliance for SCIMQ on cross-functional business initiatives, QMS activities and projects.
Qualifications, Knowledge And Skills Required
  • Bachelor’s degree in Sciences
  • 5 to 7 years of demonstrated experience in Quality Assurance (operations, systems, etc.) in a pharmaceutical company or other health care related industry
  • Demonstrated experience in a Global function is an advantage.
  • Knowledge and experience in quality systems and compliance, quality operations, distribution and international regulations are essential.
  • Knowledge of GMPs, GDPs, PIC/S and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001 2000 regulations; and requirements for pharmaceutical products distribution.
Additional Professional And Personal Requirements Include
  • Executing for Results Maintains high standards of performance for themselves and others and follows through on commitments. When faced with challenging obstacles, persists over a significant period of time to achieve his/her agenda. Conveys a sense of urgency and drives issues to closure. Makes timely decisions when a quick response is required and a number of possible alternatives are available.
  • Building Relationships & Influencing Establishes credibility and earns respect with a diverse set of internal and external cross functional stakeholders. Is articulate and makes arguments in a clear and compelling manner. Has excellence negotiation skills and achieves a win-win outcome in difficult situations.
  • Enterprise Mindset Understands the big picture, beyond their own functional area. Leads within the broader internal and external network and seeks to have impact on organization-wide performance. Embraces complexity but strives for simplicity. Shares resources and makes difficult trade-offs to benefit the organization at large.
  • Change Agility Creates a vision for the future by spotting strategic opportunities for breakthrough performance. Translates the case for change into actionable plans for the organization. Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.
  • Digital Dexterity Possesses strong desire to exploit existing and emerging technologies for better business outcomes, is a digital adopter and a flexible learner.
Why you should apply
  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package
  • Bristol Myers Squibb has been certified as a Great Place to Work in Switzerland! Each day, our collaborative teams come together to support some of the most interesting work of their careers.
For more information about Bristol Myers Squibb, visit us at https //careers.bms.com

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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Deadline: 05-05-2024

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