Senior Validation Lead
Location: POL - Wroclaw
Time Type: Full time
Job Description
What will you be doing?
- Coordinate computer system validation and assurance activities in line with global and local regulations, including 21 CFR Parts 11, 210/211, and 820.
- Advise IT teams and business users on regulatory requirements and compliance strategies.
- Support change control processes and conduct periodic reviews to maintain validated systems.
- Partner with internal and external auditors during compliance audits.
- Stay ahead of regulatory changes by engaging in continuous learning and collaboration with global teams.
- Promote adherence to IT policies, standards, and guiding principles across projects and processes.
What will you need to be successful?
- A degree in Computer Science, Life Sciences, Engineering, or equivalent experience.
- At least 4 years of experience in GxP Computer System Software Validation, including knowledge of CSA and GAMP 5.
- Familiarity with validation in Agile environments and experience with cloud computing in healthcare.
- Strong decision-making and relationship-building skills, with a consultative approach and a focus on continuous improvement.
You. Unlimited.
We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.
Inclusion & Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about our Employee Inclusion Groups on our website
Your Future: Generous annual bonus, life insurance, Save As You Earn share options.
Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
Your Wellbeing: Private Health and Dental plans, multisport card/my benefit platform and much more.
Flexibility: Hybrid Working Model (For most professional roles).
Training: Hands-On, Team-Customised, Mentorship, subsidies for language classes, certifications and postgraduate studies
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Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.
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