Senior Validation Manager
hace 4 semanas
**Senior Validation Manager**
**-**
**232756**
- At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective._
- Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve._
**Senior Validation Manager**
The VM holds the overall responsibility that GxP-relevant systems are kept in a validated state at any point in their life cycles, that the validation is carried out in accordance with the current regulatory requirements by following BI validation approach, that the validation activities are completed in a well-defined, cost-efficient and harmonized manner. This position requires a deep understanding of global business requirements, a quality mindset and highly developed project management and team leadership skills.
**Tasks and responsibilities**
- Planning and management of validation activities for GxP Global Enterprise Applications (i.e. Identity Management, IT Service Management ) during the whole system lifecycle.
- Ensure the maintenance of the system lifecycle documentation by following BI validation approach.
- Responsible to define / refine the validation strategy in an efficient risk and critical thinking-based way.
- Support to setup governance and environment run optimized for validation.
- Presentation of the selected validation strategy and the related documentation during inspections and audits.
- Management of deviations, CAPAs and changes during the operational phase of the system
- Support in the Data Integrity principles compliance.
**Requirements**:
- Degree in Computer Science, Engineering, Health Sciences (Chemistry, Pharmacy, Biology...) or comparable professional experience. At least 5 years professional experience in IT with focus on validation in a GxP environment.
- Pharma Industry related Regulations and Guidelines knowledge is mandatory (GxP, 21CFR, Data integrity, GAMP 5, etc ).
- Agile model knowledge is a plus (i.e. scrum, Kanban...).
- Experience in supporting Computerized Systems Validation Life cycle documentation (VP, URS, FS, RA, IQ, OQ”, TMX,...)
- Experience in supporting Deviations and CAPAs
- Experience in developing and training the applicable Standard Operating Procedures as defined in Validation Plans
- Negotiation skills. Ability to influence and manage conflicts minimizing the workload for system leads and SMEs to keep the system in a compliant state.
- Excellent spoken and written English
- Experience working in a virtual, international, and multicultural environment
- Excellent organizational and analytical, results oriented, good communication, teamwork, and collaboration skills
- Willingness and readiness to travel occasionally.
- #IamBoehringerIngelheim because _
- With us, you can grow, collaborate, innovate and improve lives. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, flexible learning and continuous development for all employees is key, because your growth is our growth._
- We are continuously working to create a great employee experience. These are some examples of how we will take care of you:_
- _Flexible working conditions_
- _Life and accident insurance_
- _Health insurance at a competitive price_
- _Investment in your learning and development_
- _Gym membership discounts_
- If you have read until here, what are you waiting to apply? We want to know more about you_
**Puesto**
- Tecnología de la Información
**Ubicación principal**
- Europe-ES-Cataluña-Sant Cugat del Vallès
**Organización**
- ES-Boehringer Ingelheim España, S.A.
**Horario**
- Tiempo completo
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