Senior QA Discrepancy & CAPA Lead

Bayer (Schweiz) AG; Berkeley (CA); On-site; USD 115,000 - 173,000; Full time

Job summary

Bayer is seeking a Sr. Specialist in QA Discrepancy Management for Berkeley, CA to evaluate incident reports and CAPAs under cGMP, collaborating with QA, QC, operations, and suppliers. You will lead investigations, train staff, write SOPs and drive continuous improvement.

The role requires a scientific degree, extensive GMP experience, strong leadership, and the ability to manage multiple priorities in a regulated biopharma environment.

Qualifications

• Bachelor's degree in a scientific/technical field required.
• Significant experience in biopharmaceutical, biologics, medical device or related industry with GMP knowledge.
• Multiple years in Manufacturing and/or Quality within a GMP-regulated environment.
• Ability to review and approve incident reports (discrepancies) and CAPAs.
• Strong leadership, communication and stakeholder management skills.

Responsibilities

• Represent QA in interactions with QA, QC, operations, supply chain and suppliers.
• Review and approve incident reports and CAPAs; trend data in discrepancy systems.
• Lead investigations for high-risk issues and provide scientific evaluation.
• Train and mentor internal customers; write and revise SOPs.
• Support continuous improvement and regulatory compliance activities.

Skills

GMP Knowledge

Cross-functional leadership

Quality mindset

Analytical thinking

Communication

CAPA review

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Bayer is seeking a Sr. Specialist in QA Discrepancy Management for Berkeley, CA to evaluate incident reports and CAPAs under cGMP, collaborating with QA, QC, operations, and suppliers. You will lead investigations, train staff, write SOPs and drive continuous improvement.

The role requires a scientific degree, extensive GMP experience, strong leadership, and the ability to manage multiple priorities in a regulated biopharma environment.