Associate Director - Quality Projects and Vendors

at  BristolMyers Squibb

WORKING WITH US

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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 Quality Projects and Vendors Associate Director is part of the Quality Operations team of BMS Boudry, Switzerland.

He/She is responsible to manage a team, accountable for :

• the Quality Vendors management system for all the materials and Contract Service providers used at Boudry site.
• the activities related to the quality systems to enable Boudry site to run with the new CAPABLE building P3 (CAPEX project) and the current P1 building, as well as to enable the site to manufacture clinical batches for the New Products.
• the activities necessary to ensure GMP inspection readiness of the new P3 building.

This position is key to provide the agility necessary to introduce late-stage development and early commercial new products, while maintaining routine activities for commercial products and to support the site growth through projects with the installation of the new equipment in both the current P1 and the future P3 buildings. The core mission is to guarantee all the quality aspects for some projects activities and Supplier/Material/Contract Service Providers activities are efficiently and timely managed in compliance with BMS Global Processes & Policies, Standard Operating Procedures, and GMP requirements & regulations.
As a key member of the Quality Projects & Vendors team, this position has direct reports.
On top of these responsibilities, he/she can act as a deputy of his/her Quality Projects & Vendors peers as well as of the Quality Projects & Vendors Lead.

The following responsibilities and tasks are under the position holder’s responsibility on behalf of the Qualified Person :

• Approval of documentation related to Suppliers/Material/CSPs qualification and maintenance activities.
• Batch release

This position is located at the BMS Boudry site.
The following duties apply for Celgene International (CIS) (Boudry)

Projects (for both CAPEX projects >500K and New Product Introduction):

• Responsible with the Quality Systems & Compliance team and the QA representatives on projects to define and implement the appropriate adjustments needed on the Quality Systems to enable the Boudry site to be agile with launch of new products, while continuing production of commercial products
• Work also with the team to prepare inspection readiness for the new P3 building
• Support all the activities part of the operational readiness of projects (i.e. Quality systems related activities, risk management, documentation, training, etc…)
• Responsible to define and implement the requirements for clinical production in Boudry.
• Work with internal/external stakeholders such as development, AS&T, MS&T, PMO, manufacturing and Global functions
• Monitor the best practices both internally and externally, through comprehensive benchmarking, and proceed with their implementation on Boudry site
• Participate actively to regulatory submissions.
• Participate actively to inspections / audits site readiness.

Vendor quality:

• Ensure deployment and implementation of BMS global processes for Vendor management and Material qualification in Boudry site.
• Responsible for Vendor quality activities in Projects, and New Product Introduction and work on strategy definition for new excipients/packaging materials, suppliers and CSPs.
• Lead qualification process of all suppliers/vendors/CSPs and ensure their compliance with standards and expectations.
• Manage Quality Agreements management as contract giver and acceptor
• Responsible for the vendor quality processes life cycle (deviations, CAPAs, Change controls, Supplier Change Notification, on-site supplier visit, complaints, Vendor KPIs monitoring) in close collaboration with Procurement, Operations, Quality, Supply Chain and SMEs
• Support selection of new vendors with Procurement, PMO and MS&T teams (product/material specifications, defect library, satellite samples, quality agreements, etc…).
• Monitor best practices both internally and externally, through comprehensive benchmarking, define the implementation strategies and roll out.
• Participate actively to inspections / audits site readiness.

Continuous improvement:

• Promote a continuous improvement culture within the department.
• Work closely together with the other stakeholders to identify opportunities and ensure improvement and alignment of the Quality Management Systems.

Other:

• Responsible as QP delegate to perform batch release
• Participate actively to the lifecycle of the strategic site Quality Operations plan with cooperation with stakeholders.
• Assign tasks to direct reports in accordance with their responsibilities, capabilities and qualifications and ensure individual objectives setting, performance review and their continuous professional development.
• EHS: As Line Manager, provide a safe and healthy work environment for his/her staff in areas under his/her control and shall ensure compliance with relevant rules and legislation in those areas

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.

He/She is responsible to manage a team, accountable for :

• the Quality Vendors management system for all the materials and Contract Service providers used at Boudry site.
• the activities related to the quality systems to enable Boudry site to run with the new CAPABLE building P3 (CAPEX project) and the current P1 building, as well as to enable the site to manufacture clinical batches for the New Products.
• the activities necessary to ensure GMP inspection readiness of the new P3 building

The following responsibilities and tasks are under the position holder’s responsibility on behalf of the Qualified Person :

• Approval of documentation related to Suppliers/Material/CSPs qualification and maintenance activities.
• Batch releas