Senior Manager, Quality Projects

Job content

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more careers.bms.com/working-with-us.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 (NPIs) relying on flexible manufacturing and testing operations. The Senior Manager - Quality Projects & Vendors will join the Quality Operations team of BMS, Switzerland.He/She will represent Quality in cross-functional project teams and will provide Quality oversight for the operations accomplished in the frame of projects and new product introductions for the Boudry site (including quality assurance and control aspects).The core mission is to ensure all quality aspects are efficiently managed to ensure on time delivery of projects in compliance with BMS Policies, Standard Operating Procedures, and GMP requirements and regulations.The position will also contribute to establishing a continuous improvement mindset within the quality organization & partners.He/She can act as deputy of his/her peers, as well as of the Quality Projects and Vendors Lead.This position is located at the Boudry site.Required Competencies Knowledge, Skills, And Abilities

• At least 8 years’ experience in Quality Assurance and/or Quality Control in a pharmaceutical/biotechnology industry.
• Thorough understanding of GMPs, and EMA, Swissmedic, and FDA regulatory requirements.
• Strong 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.
• Demonstrated experience in Regulatory strategies and tactics.
• Solid knowledge in project management.
• Demonstrated ability to build relationships and foster team cohesion.
• Excellent management and negotiation skills.
• Ability to motivate and engage teams across functions.
• At ease to work and to coach teams in a matrix environment.
• Proactive, strong ability to adapt rapidly to changes.
• Demonstrated experience in Lean Manufacturing culture and visual management.
• Effective communication skill and organizational skills.
• Fluency in French and English.

Duties And ResponsibilitiesProjects (including New Product Introduction)

• Act as the Quality Operations representative and single point of contact for QA, QC, Compliance, Quality Supplier and QA e-systems, within the project teams.
• Coordinate and drive quality activities related to
• Quality Assurance documentation and processes
• Technology tech transfer
• Analytical tech transfer
• Raw materials introduction
• Supplier qualification
• Specifications
• Conduct assessment of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs.
• Responsible for ensuring on time implementation of the quality-related deliveries.
• Lead the execution or is accountable for Quality (QA and QC) deliverables, including Quality approval of documentation, Quality oversight of validation & qualification activities, deviations & CAPAs, and Change Control handling.
• Coordinate with QC the evaluation and the planning of the project-related testing activities in alignment with the testing planning/capacity.
• Manage the quality aspects’ coordination with internal/external stakeholders such as quality, development, AS&T, MS&T, PMO, manufacturing.
• Contribute to lean transfer from development and/or launching manufacturing sites to operations.
• Monitor the best practices both internally and externally, through comprehensive benchmarking, defines the implementation strategies and roll out.
• Act a Site Quality Liaison for support to regulatory submissions, if necessary.
• Participate actively to inspections / audits site readiness.

Continuous improvement

• Strong involvement in the continuous improvement plan for the Site Quality Operations in collaboration with the GIM OE team, and global OE.
• Promote continuous improvement in day-to-day activities.
• Contribute to cost/time saving initiatives and sustainability projects.

Quality operations

• Participate actively in the lifecycle of the strategic site Quality operation plan in cooperation with stakeholders.
• Support the development of a meaningful KPI structure as a basis for continuous improvement.
• Act as QA approver for project-related quality records, drive change controls upon requests

EHS

• Ensures 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
• Promotes safe practices and behaviors, verify that EHS rules are implemented and respected

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 CareersWith 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.