Senior Corporate Quality - QA IT Validation

Real; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Real is seeking an experienced QA professional to lead the validation and control of GxP computerized systems in line with FDA/EU regulations. You will guide CSV strategies and partner with IT to ensure lifecycle compliance across enterprise applications supporting GxP operations.

You will review validation artifacts, provide risk-based oversight, and act as the QA approver for change controls. Strong documentation and communication skills are essential.

Qualifications

• Experience with GxP computerized systems and validation lifecycle.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH guidelines.
• Ability to lead CSV/CSA activities and risk-based validation.
• Strong attention to detail and regulatory documentation.
• Experience coordinating with IT and cross-functional teams.

Responsibilities

• Lead QA on cross-functional teams for implementation, validation, and maintenance of GxP systems.
• Ensure compliance with company policies, procedures, and regulatory requirements for validation.
• Provide guidance on validation strategies, risk-based approaches, and lifecycle expectations.
• Collaborate with business owners and CSV personnel to support validation activities.
• Review and approve validation docs including risk assessments and validation summaries.
• Serve as QA approver for IT change controls and related validation activities.
• Execute and approve periodic reviews for GxP systems.

Skills

GxP knowledge

CSV validation

Regulatory guidance

Independent worker

Communication skills

Education

Bachelor's degree in science/engineering/CS

Tools

Veeva

Oracle

LabVantage

TraceLink

GAMP5

Job description

This role will be responsible for ensuring GxP computerized systems are validated and controlled in compliance with local (e.g. 21 CFRT parts 11, 58, 210, 211) and international (e.g. Eudralex and ICH Q7) guidelines. This individual will lead the qualification efforts in collaboration with IT using the SDLC of enterprise and server-based applications supporting GxP operations. Additionally, the individual will be responsible for providing Quality oversight of laboratory systems and instrumentation qualification efforts.

Job Responsibilities:

• Lead and represent QA on cross-functional teams supporting implementation, validation, and maintenance of GxP computerized systems.
• Ensure compliance with company policies, procedures, and regulatory requirements governing computer system validation.
• Provide guidance and oversight on validation strategies, risk-based approaches, and compliance expectations throughout the computerized system lifecycle.
• Collaborate with business owners, system owners, and CSV personnel to support risk-based validation activities and resolve any compliance-related issues.
• Review and approve validation lifecycle documentation, including risk assessments, URS, FRS, CS, test protocols, and validation summary reports.
• Serve as the QA approver for IT-related change controls and associated validation activities.
• Execute and approve periodic reviews for GxP computerized systems.

Must-Haves:

• Bachelor's degree in a scientific, engineering, computer science, or related discipline.
• 6+ years of relevant experience in the biopharmaceutical or pharmaceutical industry.
• Direct experience in GxP computerized system validation (CSV/CSA), risk-based validation methodologies and system lifecycle management.
• Solid knowledge of applicable of regulatory requirements and industry best practices, including FDA CSA Guidance for Industry, 21 CFR Part 11, EU Annex 11, ICH guidelines, GAMP 5.
• Ability to work independently and collaboratively within a team with minimal direction.
• Excellent attention to detail and strong organizational and communication skills, both written and verbal.

Nice to Haves:

• Experience with validating a broad spectrum of enterprise computerized systems, such as Veeva (Quality, RIM, Safety, Clinical), Oracle, TraceLink, LabVantage, Statistica.
• Experience with qualifications of computerized laboratory equipment and infrastructure.

EOE Statement:

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.