Validation Manager
About the job
Our Team:
Cell Therapy Amsterdam, a Sanofi company, is leveraging the natural strengths of human immune systems to source the best cells to produce innovative therapies for life-threatening disease. We are focused on Natural Killer (NK) cell.
In support of our innovative NK cell therapies, we are looking for a Validation Manager .
As V alidation M anager you will document the design , , inspect ions , calibrat ions , test s , and any modif ications to the instrumentation, equipment, mechanics, and utilities. You will write new or adapt existing procedures to meet company and GMP requirements within a complex global organization on a huge variety of equipment and services. You will manage a team of consultants and are able to shift in numbers hired in time to cope with business demands.
You will ensure all systems and services comply with quality and safety to produce controlled high-quality products. You will also lead root cause investigations of equipment failures and anomalies and decide when to initiate a deviatio n or change control or quantify a CAPA . You are an active participant of the site deviation platform, in wh ich new and ongoing quality issues are discussed and for instance deviations are rated.
Main responsibilities:
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Managing a team of 3-4 engineers
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Equipment qualification
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Facility and utilities qualification
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creating and owning SOPs related to maintenance/ equipment/facility/utility qualification and validation
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managing and initiating the hire of validation engineers
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developing and testing design specifications
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monitoring and testing equipment/facility/utility (IOPQ)
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analysing and documenting test results
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preparing compliance reports
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directing validation & qualification activities
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adjusting or improvements to equipment and processes
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creating databases to track validation activities
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interpreting customer requirements
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developing qualification & validation schedules, including re-qualification as needed
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conducting training and overseeing /guiding the work of maintenance engineers and external technicians with GMP mindset and guidelines
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actively drive your (and participate on others) change controls, deviations, CAPAs
About you
Educattion :
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You have at least a relevant high school degree
Experience:
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You have over 10-years of experience in an international Pharma/GMP environment preferable in cell therapy in a quality organisation
Technical skills:
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Good knowledge of MS Office and worked on a regular basis in an electronic QMS
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You are familiar with applicable pharmaceutical standards both in Europa (EMA) as in America (FDA) like Eudralex , Pharmacopea , ATMP, ISPE, etc
Soft skills:
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You are an excellent organizer and communicator who thinks ahead, knows how to prioritize, and executes tasks in accordance with the timelines.
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You are able to scale up or down in the external validation workforce available when needed.
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You can lead multi-disciplinary teams for instance during root cause analysis or deviations.
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Good command of English language (both written and oral), preferable Dutch as well. Working language will be English.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.