Senior Corporate Quality - QA IT Validation

Real Staffing; United States; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Health savings accounts

Retirement savings plan

Life and disability insurance

Paid leave

Job summary

Specialist Staffing Group is seeking a QA professional to lead validation efforts for GxP computerized systems in the biopharmaceutical space. You will collaborate with IT and business owners to ensure risk-based validation across the system lifecycle.

The role requires extensive knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH guidelines, and GAMP 5, with a focus on quality oversight and regulatory compliance. Strong communication and independent work capability are essential.

Qualifications

• 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 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.
• Previous QA Validation experience.

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.

Skills

CSV validation

GxP experience

Regulatory knowledge

Quality oversight

Documentation

Independent work

Education

Bachelor's degree in a scientific, engineering, computer science, or related discipline

Tools

Veeva

LabVantage

TraceLink

Oracle

Statistica

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.
• Previous QA Validation experience.

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.