GMP Validation Lead for Quality Assurance & Systems

Bayer AG; Berkeley (CA); On-site; USD 118,000 - 177,000; Full time

Job summary

Bayer is seeking a QA Validation Specialist in the United States to oversee qualification and validation across manufacturing processes, facilities, utilities, equipment, and computerized systems within a GMP framework.

You will collaborate with Manufacturing, Engineering, QA, IT and project teams; review validation docs; enforce 21 CFR Part 11 compliance; and lead remediation of discrepancies to uphold quality and regulatory standards.

Qualifications

• GMP experience in pharmaceutical/biotech/medical device validation.
• Experience with validation lifecycle for manufacturing systems and facilities.
• Knowledge of FDA 21 CFR Part 11, ICH guidelines, and data integrity.
• Ability to author/approve validation protocols and reports with attention to detail.
• Understanding of QA systems: change control, CAPA, audits readiness.
• Strong analytical and cross-functional collaboration skills.

Responsibilities

• Provide QA oversight for qualification and validation of processes, facilities, and systems.
• Lead validation activities and ensure regulatory alignment and risk-based approaches.
• Review/approve qualification docs, URS, IQ/OQ/PQ, risk assessments, and traceability matrices.
• Maintain and improve site validation programs, SOPs, and master plans.
• Identify compliance issues and drive remediation with cross-functional teams.
• Oversee SOPs for technical systems and ensure high-quality documentation.
• Support investigations related to validation discrepancies and changes.
• Represent validation strategy during audits and inspections.

Skills

GMP experience

Validation lifecycle

Regulatory knowledge

QA systems

Analytical thinking

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in science/engineering

Advanced degree preferred

Tools

SAP

MES

LIMS

DCS/PLC/SCADA

Data historian

Job description

Bayer is seeking a QA Validation Specialist in the United States to oversee qualification and validation across manufacturing processes, facilities, utilities, equipment, and computerized systems within a GMP framework.

You will collaborate with Manufacturing, Engineering, QA, IT and project teams; review validation docs; enforce 21 CFR Part 11 compliance; and lead remediation of discrepancies to uphold quality and regulatory standards.