CSA Validation Lead - Life Sciences & Regulatory

Global Business Ser. 4u; New York (NY); Hybride; USD 90 000 - 140 000; Plein temps

Résumé du poste

Global Business Ser. 4u is seeking a CSA Validation SME in New York City, operating hybrid with local engagement in Long Island City. The role ensures CSA project integrity, assesses risk, and confirms compliance with regulatory and data integrity requirements.

The candidate should have extensive Medical/Pharma/GxP experience, strong communication and leadership, and familiarity with GDP, CAPAs, and 21 CFR Part 11; Agile experience is preferred.

Qualifications

• Bachelor's degree in CS/IT/Engineering or related field
• 7–10+ years in Computer System Validation/CS Assurance
• GAMP 5 and 21 CFR Part 11 knowledge
• Experience in a life sciences/GxP environment
• Strong communication and leadership with collaborative style
• Agile experience preferred

Responsabilités

• Provide insight on validation project risk and complexity
• Maintain validation best practices
• Collaborate with system owners to gather information
• Work with Business Analyst on a frequent basis
• Ensure GDP compliance in all activities
• Draft and review Reports (VSR, VP, TP, RA) as needed
• Collect feedback from System Owners on deliverables
• Prepare and execute validation documentation as required
• Draft, review, and execute other validation documents when necessary

Connaissances

CSA Validation

Regulatory Compliance

Communication

Leadership

Agile

Formation

Bachelor's Degree (CS/IT/Engineering)

Description du poste

Global Business Ser. 4u is seeking a CSA Validation SME in New York City, operating hybrid with local engagement in Long Island City. The role ensures CSA project integrity, assesses risk, and confirms compliance with regulatory and data integrity requirements.

The candidate should have extensive Medical/Pharma/GxP experience, strong communication and leadership, and familiarity with GDP, CAPAs, and 21 CFR Part 11; Agile experience is preferred.