Sr. Manager Quality BMS Benelux – CLS EU Branch – Responsible Person NL

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Job Title:

Sr. Manager Quality BMS Benelux – CLS EU Branch – Responsible Person NL

Employee, Full Time

Location(s): Utrecht, NL

Department Name: Supply Chain & In-Market Quality

Key Responsibilities and Major Duties:

The Sr. Manager Quality BMS Benelux / CLS EU Branch – Responsible Person NL is a position based in The Netherlands.

As Responsible Person, the Senior Manager is responsible for the activities in scope of the Wholesale Distribution Authorizations (WDA) of BMS Netherlands and BMS Celgene Logistics Sarl (CLS) EU Branch, in accordance with the EU Guidelines of Good Distribution Practices of Medicinal Products for Human Use.

More specifically:

Ensures that a Quality Management System is implemented and maintained in BMS Benelux as well as for BMS CLS EU Branch, including:

• Maintaining Quality System Documentation: procedures and records
• BMS Policy/Directives/SOPs impact assessment and implementation
• GDP and Local regulations impact assessment and implementation
• Focusing on the management of authorized activities and the accuracy and quality of records
• Ensuring that initial and continuous GDP training programs are implemented and maintained.
• Developing and maintaining the respective Quality Manuals
• Ensuring that relevant customer complaints (incl. potential counterfeit) are dealt with effectively.
• Performing periodic Self-Inspections according with the Self inspection plan
• Ensuring implementation of Deviation and CAPA management
• Ensuring implementation of the Change Control management
• Leading/co-chairing the Quality Council meetings
• Ensuring the reporting of quality metrics

Ensures implementation of following Quality Operations:

• Supplier Management: Quality Agreements, approving any locally subcontracted GDP-activity which may impact product quality.  Evaluate and confirm the overview of the supplier qualification status.
• Customer Qualification – approve new customers and periodic customer verification
• Support investigations of GDP-compliance deviations and product quality issues with the relevant stakeholders.
• Ensures proper escalation of quality incidents within quality, supply chain and the business.
• Attends fact finding meetings when required and implements the defined action plans within the market.
• Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls.
• Supports Supply Chain to avoid back-orders.
• Oversight on product quality status.  Maintenance and approval of the GDP-release register (Benelux)
• Keeps appropriate records of any delegated duties.

Specifically for BMS Netherlands :

• Approves returns to saleable stock, according to BMS requirements
• Provide quality input on shortage situations and oversight reporting to Health Authority
• Support Supply Chain to avoid Back Orders
• Decides on the final disposition of rejected, recalled or falsified products.
• Have oversight of the Third Party Logistics (3PL) and attend/ensure attendance in 3PL periodic Business Reviews for the Benelux
• Representative for any communication with Health Authorities related to distribution and product quality defects
• Provide back-up and support to Quality Operations of BMS Belgium.

Facilitate that BMS requirements are implemented in the Local Distribution Centre for:

• Warehousing facilities
• Transportation processes

Quality Risk Management

• Coordination and preparation of Quality Risk Management
• Participate in the periodic Business Reviews with the Distribution Center

Inspections and Regulatory Surveillance<