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Smith+Nephew • Wrocław, Lower Silesian Voivodeship, Poland
Salary: 21 CFR Pa
Role & seniority: Senior Validation Lead (IT compliance and validation in a regulated environment)
Stack/tools: GxP Computer System Validation; CSA; GAMP 5; Agile validation; cloud computing in healthcare; regulatory audits
Coordinate computer system validation and assurance activities per global/local regulations (e.g., 21 CFR Parts 11, 210/211, 820)
Advise IT teams and business users on regulatory requirements and compliance strategies; support change control and periodic reviews
Partner with internal/external auditors during compliance audits and stay ahead of regulatory changes through cross-team collaboration
Degree in Computer Science, Life Sciences, Engineering, or equivalent
≥4 years in GxP Computer System Software Validation; knowledge of CSA and GAMP 5
Familiarity with validation in Agile environments and cloud computing in healthcare
Strong decision-making, relationship-building, and a consultative, continuous-improvement mindset
Continuous learning mindset; experience across global/regional regulatory frameworks
Experience working with cross-functional teams and audits in healthcare/regulated settings
Location & work type: Hybrid working model; global healthcare company (location not specified)
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about IT compliance and validation in a highly regulated environment? Join us as an Senior Validation Lead and play a key role in ensuring our systems meet the highest standards of quality and regulatory compliance. This is your chance to make an impact in a global healthcare organization while working in a collaborative and innovative team. What will you be doing? In this role, you’ll be at the heart of our IT compliance efforts, ensuring that computer systems remain validated and compliant. You will: 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? Success in this role means being a trusted advisor and a proactive problem solver. You’ll need: 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 #LI-GG1 Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. 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. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.