Sant Cugat del Vallès, ESP
1 day ago
Validation Manager
We are building Boehringer Ingelheim’s Enterprise Development Platform (EDP) to facilitate the development, delivery, and operations of digital products and use-cases by ensuring fast time-to-market, compliance at the same time, all provided through great user experience. As EDP validation manager, you play a key role in ensuring the necessary actions take place to keep the platform in a compliant state. That enables EDP users to validate and deliver their digital products in a compliant way too. **Tasks and responsibilities** + For every new EDP component/feature as well as the existing EDP, you ensure the appropriate validation/qualification activities take place in order to comply with the validation planning and applicable Boehringer Ingelheim internal regulations. + You ensure all system specific SOPs (Standard Operating Procedures) and SLC (System Life Cycle) documentation are in place prior to operation phase. + You ensure the validation status of the system is maintained after the system is in operation. + You act as Subject Matter Expert for validation related topics + You actively connect with EDP onboarding and support team as well as EDP product development teams to spread the knowledge and create awareness about Compliance related topics **Requirements** + Degree in Computer Science or comparable professional experience + At least, 3 years professional experience in IT with focus on validation in a GxP environment + Experience in supporting Quality Management Systems and System Life Cycle Documentation (e.g. Validation Plan, User Requirements, Functional Specifications, Risk Assessment, Testing Reports,…) will be appreciated + Professional experience with Continuous Integration/Continuous Delivery frameworks, tools, and technologies, such as Jenkins and Atlassian will be a bonus + 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 platform SMEs to keep the system in a compliant state. + Pharma industry and GxP knowledge is mandatory + 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… We are continuously working to design the best experience for you. Here 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 this far, what are you waiting for to apply? We want to know more about you! All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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