Manager, Computer Software Assurance & ValidationDepartment: Ops Tech & Automation
Employment Type: Full Time
Location: Research Triangle Park, NC
Role OverviewThe Manager, Computer Software Assurance & Validation, leads Kriya's CSV program. This role sets validation strategy, drives continuous improvement, and enforces data integrity controls across computerized systems. The Manager engages at every stage of software implementation, from planning through retirement, and ensures compliance with applicable regulatory requirements.
Key Responsibilities- Lead the Computer System Validation (CSV) program, including lead and manage continuous improvement efforts for the CSV program.
- Implement risk-based computer system validation approach/methodologies based on GAMP 5, including critical thinking and computer software assurance (CSA) approach.
- Provide oversight for the CSV program; provide input to, author, revise in creation, support and maintenance of SOPs, work instructions or forms.
- Represent CSV on projects/initiatives, and provide input into the planning, development, and implementation of computer systems validation documentation.
- Oversee the development of validation documentation (e.g., System Impact Assessment, User Requirements Specification, Validation Plan, Risk Assessment, Test Protocols, and other deliverables) according to CSV procedures and following the CSA approach regarding testing.
- Review and audit of computer system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements.
- Ensure the execution of data integrity assessments, including resolution/mitigation of gaps identified through validation testing or procedural controls.
- Partner with Business Owners and Quality to ensure data integrity controls are effective and compliant.
- Review and approve change control activities for computerized systems.
- Own and maintain the computerized system inventory.
- Provide CSV oversight for manufacturing-related systems, including domain and process-controlled systems, building monitoring and alarm systems, and process historians.
- Partner with Automation, Manufacturing, and Facilities to validate computerized systems supporting GMP production, utilities, and building management.
- Ensure manufacturing systems maintain a validated state across implementation, change control, periodic review, and retirement.
- Review and approve periodic review activities for computerized systems.
- Provide leadership and guidance to and collaborative with cross-functional teams to accomplish company objectives and team goals to support on-time completion of system go-lives and enhancements.
- Oversee creation/authoring of standard operating procedures, policies, and validation master plan on an as-needed basis as it relates to the CSV program.
- Oversee contract validation support.
Experience & Skills and Work EnvironmentExperience & Skills- Minimum bachelor's degree in engineering or life science related field.
- Minimum seven (7) years of CSV experience in cGMP pharmaceutical or biopharmaceutical environments.
- Deep knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820), GAMP 5, and risk-based computer software assurance.
- Experience validating domain- and process-controlled systems, building monitoring/alarm systems, historians, and test automation tools/frameworks.
- Experience with laboratory analytical instrument qualification and cloud-based validation.
- Strong knowledge of data integrity practices, including MHRA and PIC/S guidance.
- Working knowledge of FDA, EU, and ICH regulations, with experience supporting regulatory inspections.
- Excellent communication, technical writing, and time management skills.
- Strong interpersonal and organizational skills, with attention to detail, proactive problem-solving, and effective collaboration across all levels of the organization.
- Proven ability to independently lead multiple CSV projects for complex systems and digital initiatives, managing testing efforts and ensuring compliance.
Work Environment- Primarily desk-based, generally in an office or home office setting.
- May involve extended periods of sitting and computer use.
- This is an onsite role at our Research Triangle Park site.
Rewards & Benefits- Time Off & Work-Life Balance: Flexible Time Off • Paid Parental & Medical Leave • Paid Company Holidays
- Health & Wellness: Fertility & Family Building Benefits • Medical, Dental, and Vision Insurance • Employee Assistance Program (EAP) • Life Insurance • Short- and Long-Term Disability Coverage
- Financial Security:Equity • 401(k) with Company Match • Identity Theft Protection
- And More!
