Senior Specialist, QA Disposition

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Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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: Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years employing people across a range of activities and business units in Utrecht The Netherlands.

The Netherlands is also home to our first European Cell Therapy facility located at the Leiden Bio Science Park the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it!

The Netherlands has everything it takes to become the medicines hub of Europe the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site we are looking to grow our team.

Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer Join us and be a game changer!

For more information about Bristol Myers Squibb Netherlands visit us at or Summary

The Senior Specialist QA Disposition is responsible for quality and disposition activities at the Cell Therapy Facility (CTF) in Leiden The Netherlands in accordance with Bristol Myers Squibb (BMS) policies standards procedures and Global current Good Manufacturing Practice (cGMP).

Functional responsibilities include performing operational and timely preparation for deliverables for incoming materials intermediate and drug product disposition within the inventory management system (SAP).

This includes but is not limited to review and/or approval of all disposition inputs associated to materials intermediate and drug product prior to release and provides input in the development systems impacting disposition i.e. Manufacturing Execution Systems (MES) and CeLabs LIMS System.

Duties/Responsibilities

• Prepares intermediate drug product and incoming materials disposition documentation and deliverables per SOPs.
• Reviews or inspects for accuracy and acceptability of the disposition inputs and deliverables to support disposition of materials and batches including: certificate of analysis deviations lot genealogy specifications and standards.
• Performs disposition of materials and intermediate products
• Collaborates with stakeholders on non-conforming materials or batch deviation investigations reporting and corrective and preventative actions (CAPA).
• Works on assignments of moderate to high complexity where judgment is required in resolving problems and making routine recommendations.
• Develops maintains or reviews SOPs material specifications training and business processes supporting disposition.
• Coordinates with internal and external stakeholders to troubleshoot concerns and issues as required.
• Participates in Master Data management and supports master data for incoming materials.
• Provides guidance to less experienced staff with atypical events during day-to-day operations.
• May own Quality System records such as deviations CAPAs or Change Controls.
• Supports continuous improvement projects to improve efficiency of the dispositioning and related business processes.
• Supports the Disposition group at various project meetings and anticipate lot disposition impact.
• Provides support as SME for change controls deviations project teams and provide quality input in the resolution of disposition related issues.
• Supports internal and external inspections as required.
• Maintains compliance with assigned learning plan.
• Supports integration of newer team members.
• Leads meetings and represents function at cross functional meetings. Shares data/ knowledge within and across team. Builds & maintains strong relationships with partner functions.
• Advanced knowledge and experience with cGMP manufacturing quality and compliance to make appropriate decisions as needed.
• Ensures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes procedures and resources are adhered to while performing responsibilities.
• Work is self-directed and requires minimal direction to complete tasks by following work practices lists forms and/or procedures.

Reporting Relationship:

Senior Specialist Quality Assurance Disposition reports into Director Disposition Operations.

Qualifications:

• Ability to research understand interpret and apply internal policies and regulatory guidelines.
• Ability to interpret data and results understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
• Ability to work in a fast-paced team environment and changing priorities.
• Detail oriented and task focused with ability to meet deadlines and prioritize work.
• Able to work across functional groups and teams to ensure requirements are met.
• Self-motivated and contribute to a positive team environment.
• Curious and ability to think critically to create innovative solutions.
• Must be action-oriented and customer-focused and skilled in decision-making building relationships problem solving conflict management planning and organizing resource allocation coaching others and analytical thinking.
• Confident in making decisions for routine and non-routine issues. Routinely recognizes Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
• Good social skills. Ability to cooperate and adapt to changing circumstances.
• Knowledge of electronic systems including any of the following preferred: Manufacturing Execution systems (MES) Enterprise Resource Planning (ERP) SAP and Quality Management systems.

Education/Experience/Licenses/Certifications:

• Bachelors degree in engineering a life or physical science related field (including biology biochemistry chemistry) is preferred. High school diploma/ Associates degree with equivalent combination of education and work experience is acceptable.
• 4 years of directly relevant experience in a regulated cGMP environment. Previous quality experience is strongly preferred.

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