Senior QA Validation Director — Sterile GMP & Compliance

Kindeva; Maryland Heights (MO); On-site; USD 120,000 - 150,000; Full time

Job summary

Kindeva seeks a seasoned QA Validation SME to lead the validation function at our sterile injectable GMP site, providing expert oversight of equipment and utility qualification, process and cleaning validation, media fill activities, CSV, and data integrity compliance. This role shapes validation strategy and regulatory readiness across the site.

You will mentor teams, collaborate with cross-functional partners, prepare master plans and reports, and drive continuous improvement of the validation

Qualifications

• Minimum 8 years of GMP pharmaceutical manufacturing experience with QA oversight of validation programs.
• Deep understanding of regulatory requirements (21 CFR Parts 210, 211, 11; EU GMP; Annex 1; ICH Q8–Q10; WHO, PIC/S) and GAMP 5.
• Sterile manufacturing validation expertise (aseptic process simulation, media fill, cleaning validation).
• Hands-on experience with computer system validation and data integrity controls in GMP environments.
• Proven ability to collaborate in a matrixed environment and support regulatory inspections.

Responsibilities

• Serve as QA functional lead for validation, overseeing programs for facilities, utilities, equipment, processes, cleaning, and computerized systems.
• Review and approve validation master plans, protocols, reports, and risk assessments to ensure GMP compliance.
• Provide QA oversight for media fill validations and validate cleaning strategies and acceptance criteria.
• Oversee qualification of equipment and utilities (URS, DQ, IQ, OQ, PQ) with risk-based approaches.
• Review and approve CSV deliverables in line with 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Champion data integrity (ALCOA+) across validation docs; mentor QA/validation staff; support inspections.

Education

Bachelor’s or advanced degree in life sciences, engineering, or a related field

Tools

CSV validation

Job description

Kindeva seeks a seasoned QA Validation SME to lead the validation function at our sterile injectable GMP site, providing expert oversight of equipment and utility qualification, process and cleaning validation, media fill activities, CSV, and data integrity compliance. This role shapes validation strategy and regulatory readiness across the site.

You will mentor teams, collaborate with cross-functional partners, prepare master plans and reports, and drive continuous improvement of the validation