Senior Validation Lead

Smith and Nephew·
POL - Wroclaw
2mo ago
Full-timeSenior

Description

<div><div><b>Life. Unlimited.</b> At Smith&#43;Nephew we design and manufacture technology that takes the limits off living.</div><div></div><div>Are you passionate about IT compliance and validation in a highly regulated environment? Join us as an <b>Senior Validation Lead</b> 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.</div><div></div><h3>What will you be doing?</h3><div>In this role, you’ll be at the heart of our IT compliance efforts, ensuring that computer systems remain validated and compliant. You will:</div><ul><li>Coordinate computer system validation and assurance activities in line with global and local regulations, including 21 CFR Parts 11, 210/211, and 820.</li><li>Advise IT teams and business users on regulatory requirements and compliance strategies.</li><li>Support change control processes and conduct periodic reviews to maintain validated systems.</li><li>Partner with internal and external auditors during compliance audits.</li><li>Stay ahead of regulatory changes by engaging in continuous learning and collaboration with global teams.</li><li>Promote adherence to IT policies, standards, and guiding principles across projects and processes.</li></ul><h3></h3><h3>What will you need to be successful?</h3><div>Success in this role means being a trusted advisor and a proactive problem solver. You’ll need:</div><ul><li>A degree in Computer Science, Life Sciences, Engineering, or equivalent experience.</li><li>At least 4 years of experience in GxP Computer System Software Validation, including knowledge of CSA and GAMP 5.</li><li>Familiarity with validation in Agile environments and experience with cloud computing in healthcare.</li><li>Strong decision-making and relationship-building skills, with a consultative approach and a focus on continuous improvement.</li></ul><p></p><div><p><b><span>You. Unlimited.</span></b><span><span> </span></span><span> </span></p></div><div><p><span><span>We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><ul><li><p><b><span>Inclusion &amp; Belonging:</span></b><span><span><span> </span>Committed to Welcoming, Celebrating<span> </span></span><span>and Thriving on Inclusion and<span> </span></span><span>Belonging</span><span>,</span><span><span> </span></span><span>Learn more about our<span> </span></span></span><a href="https://www.smith-nephew.com/en/careers/life-at-smith-nephew#inclusion-diversity-&#43;-equity" target="_blank"><u><span>Employee Inclusion Groups</span></u></a><span><span><span> </span>on our website</span></span><span> </span></p></li></ul></div><div><ul><li><p><b><span>Your Future:</span></b><span><span><span> </span>Generous annual bonu</span><span>s,</span><span><span> </span></span><span>life insurance</span><span>, Save As You Earn share options.</span></span><span> </span></p></li></ul></div><div><ul><li><p><b><span>Work/Life Balance:</span></b><span><span><span> </span>Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!</span></span><span> </span></p></li></ul></div><div><ul><li><p><b><span>Your Wellbeing:</span></b><span><span><span> </span>Private Health and Dental plans,<span> </span></span><span>multisport card/my benefit platform</span><span><span> </span></span><span>and much more.</span></span><span> </span></p></li></ul></div><div><ul><li><p><b><span>Flexibility:</span></b><span><span><span> </span>Hybrid Working Model (For most professional roles).</span></span><span> </span></p></li></ul></div><div><ul><li><p><b><span>Training:</span></b><span><span><span> </span>Hands-On, Team-Customised, Mentorship</span><span>,<span> </span></span><span>subsidies for language classes, certifications and postgraduate studies</span></span><span> </span></p></li></ul></div><p></p><p>#LI-GG1</p><p></p></div><div><p style="text-align:inherit"></p><p style="text-align:left">Stay connected by joining our <a href="https://smithnephew.wd5.myworkdayjobs.com/External/page/4ba17039009510002b17ea5e89c40000" target="_blank">Talent Community</a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span><span>We&#39;re more than just a company - we&#39;re</span><span> a community! Follow us on <a href="https://www.linkedin.com/company/smith-&amp;-nephew/" target="_blank">LinkedIn</a></span></span><span><span> to see how we support and empower our employees and patients every day. </span> </span></p><p style="text-align:left"><br /><span>Check us out on <a href="https://www.glassdoor.com/Overview/Working-at-Smith-and-Nephew-EI_IE10233.11,27.htm" target="_blank">Glassdoor</a></span><span> for a glimpse behind the scenes and a sneak peek into </span><b>You. Unlimited.</b><span>, life, culture, and benefits at S&#43;N.</span></p></div><div><p style="text-align:inherit"></p></div><div><p style="text-align:left"><span><span>Explore our </span></span><a href="https://www.smith-nephew.com/en/" target="_blank">website</a><span><span> and learn more about our mission, our team, and the opportunities we offer.</span></span><span> </span></p><p style="text-align:inherit"></p></div><p style="text-align:inherit"></p>
Smith and Nephew

Smith and Nephew

BIOTECHNOLOGY

Sports Medicine, Trauma, Wound Care, etc.

LocationMA - Andover
Open Jobs475
RespiratoryHematology
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