Manager QA, EU Qualified Person Cell Therapy

Bristol Myers Squibb; Leiden; On-site; EUR 140,000 - 190,000; Full time

Job summary

Bristol Myers Squibb in the Netherlands is seeking a Manager QA, EU QP Cell Therapy to oversee the quality management system and act as Qualified Person for investigational and commercial ATMP products across Europe and Rest of World.

You will lead audits, release decisions, risk assessments, and continuous improvement of GMP/GDP processes while collaborating with global teams and external partners to ensure compliant, timely batch disposition.

Qualifications

• MSc in technical/scientific field and meets EU Qualified Person education requirements.
• Eligible to act as Qualified Person within EC/EEA; preferred.
• Extensive QA/QA experience in biotechnology (6+ years) including audits and investigations.
• Experience with aseptic manufacturing, biological products or cell therapy.
• Thorough knowledge of GMP/GDP requirements (EU).
• Excellent communication, interpersonal and negotiation skills.
• Strong organizational, project management and problem-solving abilities.

Responsibilities

• Act as Qualified Person per EU requirements for EU/EEA and Rest of World markets.
• Oversee and execute QA/QMS activities to ensure regulatory compliance for ATMP products.
• Perform release decisions and review non-routine quality investigations.
• Participate in GMP/GDP audits and implement corrective actions.
• Identify and implement product/process quality improvements.
• Maintain training compliance and manage quality agreements with contractors.

Education

MSc in technical or scientific discipline

Eligible to act as Qualified Person (EC/EEA)

Extensive QA/QC experience (6+ years in biotech)

Aseptic manufacturing knowledge

GMP/GDP regulatory knowledge (EU)

Strong communication skills

Organizational and project management

Problem solving and teamwork

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Manager EU QP supports in the implementation and execution of the Quality Assurance function and Quality Management System of BMS Netherlands Operations BV which will ensure product quality and compliance with all regulatory and corporate requirements for Investigational and Commercial ATMP (Gene Therapy) Products within Europe and Rest of World Markets as applicable. This position acts in its primary role as Qualified person for investigational and commercial Cell Therapy products within EU/EEA and Rest of World Markets as applicable. These duties and responsibilities are executed in accordance with the requirements of the BMS Netherlands Operations BV license and the Professional Code of Conduct.

Duties/Responsibilities

Include, but are not limited to, the following:

• Act as Qualified Person as per requirements of BMS Netherlands Operations BV licences and execute functions in accordance with Professional Code of Conduct
• Fulfil Qualified Person duties as defined in article 51 of 2001/83/EC, Annex 16, Annex 13 and the ATMP guidelines of Volume 4 of the EU GMP guidelines
• Interpret international, regional, and local regulations and apply those regulations within the GMP/GDP environment and the batch disposition process in the EU/EEA and Rest of World Markets as applicable.
• Perform the verification of QP certification of imported Advanced Therapy Medicinal Products (ATMPs) Investigational Medicinal products (IMP) into the United Kingdom in accordance with MHRA guidelines "Importing Investigational Medicinal Products (IMP) from countries on a list to Great Britain", as assigned
• Build up a deep knowledge of the cell therapy-based processes, technology and the specific treatments which are intended to be commercialized
• Interact with global, site, and vendor oversight Quality and Supply Chain functions to ensure a compliant, efficient, and timely batch disposition for cell therapies
• Participate in GMP- or GDP-related health authority inspections at Celgene Distribution BV, BMS Netherlands Operations BV and other BMS entities as required, respond to any noted observations, and ensure implementation of corrective actions
• Manage quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken
• Develop and maintain a release process which takes into account the specifics of autologous cell therapy treatments with staged release, treatment of OOS results and related risk assessments
• Conduct final review and approval of non-routine quality investigations related to batch deviations, batch disposition, and other quality systems for assigned products as required
• Identify and recommend product and process quality improvements
• Support BMS Netherlands Operations BV for implementing and maintaining and continuously improving the quality management system
• Author and/or revise procedures, work instructions, and Standards, as required
• Maintain compliance with personal training requirements
• Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
• Participate in GMP audits of suppliers, and service providers as required

Reporting Relationship:

The Manager QA, EU QP Cell Therapy reports administratively and functionally to the Director, Disposition Operations - Cell Therapy

Qualifications:

• MSc (or equivalent) in a technical or scientific discipline and meets educational requirements for EU Qualified Person as described in Article 49 2001/83/EC and any national requirements
• Eligible to act as Qualified Person within EC/EEA. Experience as Qualified Person preferred.
• Extensive quality assurance/control experience in the biotechnology industry (equivalent to a minimum of 6 years experience), including audit, batch record review, change control, complaint handling and investigations experience
• Must have experience and good knowledge of aseptic manufacturing, biological products and/or cell therapy products
• Must have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach
• Must have excellent organizational, project management and problem solving skills
• Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (EU particularly), including a good knowledge of Advanced Therapy Medicines P