UST
Website:
ust.com
Job details:
Role Description
Lead I - Software Engineering
Who We Are
At UST, we help the world’s best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 26,000 employees in 25 countries, we build for boundless impact—touching billions of lives in the process. Visit us at .
Job Summary
The IT Quality & Compliance Specialist is responsible for ensuring that computerized systems supporting regulated business processes comply with applicable regulatory requirements and industry standards. This role partners closely with IT, Quality, and business stakeholders to implement and maintain compliant, risk‑based processes for system validation, change control, data integrity, and ongoing compliance, with an emphasis on Computer System Validation/Computer Software Assurance (CSA) principles.
Key Responsibilities
IT Quality & Compliance
- Ensure computerized systems comply with applicable regulations and standards, including 21 CFR Part 11, 21 CFR Part 820, EU GMP Annex 11, ISO 9001,ISO 13485 and other applicable global regulations
- Support internal and external audits and inspections related to IT systems and validation
- Identify, assess, and mitigate compliance and data integrity risks associated with computerized systems
- Contribute to the development, review, and maintenance of IT Quality and CSV/CSA policies, procedures and guidance
Computerized Systems Validation / Assurance
- Lead or support risk‑based validation and assurance activities using CSA and/or traditional CSV approaches
- Develop and review validation deliverables such as:
- Validation Plans
- Risk assessments (system or functional)
- Test strategies and summaries
- Ensure validation activities are fit‑for‑purpose, focused on critical functions, and appropriately documented
Change and Lifecycle Management
- Review and approve IT system changes, upgrades, and configurations for compliance impact
- Assess vendor releases and changes for risk to intended use, validation state, and regulatory compliance
- Support ongoing system lifecycle activities, including periodic reviews and decommissioning activities
Vendor and Supplier Oversight
- Support vendor qualification and due diligence activities, including:
- Review of SOC reports and vendor documentation as app
- Assessment of vendor change and release management practices
- Partner with Procurement, IT, and Quality to ensure vendor controls are understood and leveraged appropriately
Stakeholder Collaboration
- Act as a trusted Quality and compliance advisor to IT and business teams
- Provide guidance and training on CSA/CSV expectations and best practices
- Promote a risk‑based, pragmatic, and value‑focused quality culture, minimizing over‑documentation while maintaining compliance
Qualifications
Education and Experience
- Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field
- Typically 6+ years of experience in IT Quality, CSV/CSA, or regulated IT environments
Required Knowledge And Skills
- Strong understanding of:
- GxP and regulated environments
- FDA and EU regulatory expectations for computerized systems
- Data integrity principles
- Experience with:
- CSA and/or traditional CSV methodologies
- Validation of SaaS, COTS, customized and configured systems
- Risk‑based approaches to testing and assurance
- Familiarity with SDLC methodologies (Agile, Waterfall, Hybrid) and tools such as Jira, Confluence, and test management systems
- Excellent written and verbal communication skills
- Ability to balance compliance requirements with business efficiency
Preferred Qualifications
- Experience supporting FDA inspections or ISO audits
- Experience in medical device, pharmaceutical, or life sciences industries
- Familiarity with cloud‑hosted and SaaS platforms
What We Believe
We’re proud to embrace the same values that have shaped UST since the beginning. Since day one, we’ve been building enduring relationships and a culture of integrity. And today, it's those same values that are inspiring us to encourage innovation from everyone, to champion diversity and inclusion and to place people at the center of everything we do.
Humility
We will listen, learn, be empathetic and help selflessly in our interactions with everyone.
Humanity
Through business, we will better the lives of those less fortunate than ourselves.
Integrity
We honor our commitments and act with responsibility in all our relationships.
Equal Employment Opportunity Statement
UST is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.
- To support and promote the values of UST.
- Comply with all Company policies and procedures
Skills
software development,fda,eu gmp annex 11,iso 9001,gxp,
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