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

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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.

Explore our website and learn more about our mission, our team, and the opportunities we offer.

Senior Validation Lead

What will you be doing?

What will you need to be successful?

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