Senior QA Validation Lead – Sterile Manufacturing

Kindeva Drug Delivery; Missouri; On-site; USD 130,000 - 160,000; Full time

Job summary

Kindeva Drug Delivery in Missouri seeks a seasoned QA Validation SME to lead our validation function at a sterile injectable GMP site. You will guide equipment and utility qualification, process validation, media fills, CSV, and data integrity, ensuring regulatory alignment and robust quality systems.

You will collaborate with Engineering, Validation, Manufacturing, IT and QC, mentor staff, and serve as SME during inspections by FDA/EMA.

Qualifications

• Bachelor’s or advanced degree in life sciences, engineering, or related field.
• 8+ years GMP pharma manufacturing 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 industry best practices (GAMP 5).
• Sterile manufacturing validation expertise: aseptic process simulation (media fill), cleaning validation, facility qualification.
• Hands-on CSV and data integrity controls in GMP environments.
• Strong cross-functional collaboration and communication skills.
• Experience representing QA validation during regulatory inspections preferred.

Responsibilities

• Lead QA validation programs for facilities, utilities, equipment, processes, cleaning, and computerized systems.
• Review and approve validation master plans, protocols, reports, and risk assessments for compliance with GMP regulations and internal procedures.
• Oversee media fill validations with proper design, execution, and documentation for sterile manufacturing requirements.
• Lead QA review/approval of cleaning validation strategies including rationale, worst-case scenarios, acceptance criteria, and continued verification.
• Provide QA guidance during qualification of equipment and utilities (URS, DQ, IQ, OQ, PQ) with a risk-based approach.
• Oversee QA review/approval of computer system validation (CSV) deliverables per 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Serve as SME during inspections (FDA, EMA, customer audits) defending validation and QA oversight practices.
• Identify and implement continuous improvement opportunities in the validation quality system and documentation lifecycle.
• Mentor and train QA and validation staff on current validation expectations and regulatory updates.

Skills

QA Validation

GMP Regulations

Data Integrity

Regulatory inspections

Education

Bachelor's or above in Life Sciences or Engineering

Tools

GAMP 5

Job description

Kindeva Drug Delivery in Missouri seeks a seasoned QA Validation SME to lead our validation function at a sterile injectable GMP site. You will guide equipment and utility qualification, process validation, media fills, CSV, and data integrity, ensuring regulatory alignment and robust quality systems.

You will collaborate with Engineering, Validation, Manufacturing, IT and QC, mentor staff, and serve as SME during inspections by FDA/EMA.