IT Validation Manager
vor 1 Tag
About the Role
We are seeking a highly skilled IT Validation Leader to join our team at Olympus. As a key member of our Global IT organization, you will be responsible for designing, implementing, and managing all operational software validation activities.
Key Responsibilities
- Work closely with Global IT functions to ensure the operation of validated environments in accordance with GMP and other regulatory requirements relevant to a MedTech company.
- Perform the initial Quality Gate Check when a new application/software is introduced to determine whether the software needs to be validated or not.
- Provide guidance to Global IT teams on the process for creating validation documentation and requirements.
- Ensure the development, review, and approval of validation documentation, including CSV/CSA Risk Assessments, change control forms, requirements, validation plans, data migration plans, IQ, OQ, PQ/UAT test protocols, test cases, and reports, and requirements traceability matrices.
- Provide expertise and advice to Global IT programs and projects on validation.
- Support the revalidation process in the event of a major change.
- Monitor the compliance of system adherence to good practice guidelines and regulations from creation of a medical device through to authorization to ISO standards (e.g., GMP, GCP, MDR, etc.).
- Document compliance and progress towards the validation plan.
- Review documentation for projects/products and platforms to ensure governance is adhered to by external and internal teams.
- Manage spot check audits to ensure projects/products/platforms change governance is adhered to.
Requirements
- Bachelor's degree in Life Science, Computer Science, or Business (or equivalent and related experience preferred).
- At least 2 years in validation, preferably with a focus on pharmaceutical, biotechnology, clinical, medical, laboratory, or other applicable areas.
- Experience in quality risk management and handling GxP regulations.
- Experience in project management, especially with regards to CSV/CSA.
- Progressive experience in a multi-national, multi-divisional technology environment with demonstrated experience in planning, forecasting, modeling, and analysis.
- Good understanding and application of FDA and regulatory requirements.
- English and German language skills.
What We Offer
- 30 days of annual leave.
- Up to 60% mobile work possible + flexible work time model with overtime compensation.
- Holiday and Christmas bonuses.
- Corporate benefits discounts for employees.
- Comprehensive company pension scheme and capital-forming benefits.
- Company restaurant with live cooking and healthy food (subsidized).
- Employee Assistance Program of FamPLUS to support your health, mental, and emotional well-being.
- Subsidy for public transportation (Deutschlandticket), free parking spaces, and bike or car leasing.
- Various subsidized company sports groups and access to the in-house company gym.
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