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!