Senior Quality Systems Lead – External Manufacturing

ACTalent; Foster City (CA); Hybrid; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance

Time Off / Leave

Job summary

Actalent seeks a Quality Systems Specialist III to lead quality oversight for external manufacturing and testing partners in a GMP environment. This hybrid role can be based in Foster City, CA or Parsippany, NJ, combining on-site and remote work.

The position emphasizes risk management, regulatory compliance, and continuous quality improvements across development, transfer, validation, and commercial supply.

Qualifications

• 5+ years of experience with a science degree or 4+ years with an advanced degree.
• Experience in GMP-regulated biopharmaceutical manufacturing and QA/QC.
• Knowledge of validation, change controls, deviation management, CAPA, and inspection readiness.
• Experience overseeing external contract manufacturing or testing organizations.

Responsibilities

• Lead quality oversight across development, technology transfer, validation, launch, and commercial supply.
• Implement external quality plans and govern outsourced manufacturing and testing.
• Elevate gaps and ensure compliance with regulatory standards.
• Coordinate Quality Agreements and oversee deviations, CAPAs, change controls, and investigations.
• Support batch release, disposition, and issue resolution to maintain product quality and supply.

Skills

Quality oversight

GMP knowledge

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in science or related field

Advanced degree preferred

Job description

Actalent seeks a Quality Systems Specialist III to lead quality oversight for external manufacturing and testing partners in a GMP environment. This hybrid role can be based in Foster City, CA or Parsippany, NJ, combining on-site and remote work.

The position emphasizes risk management, regulatory compliance, and continuous quality improvements across development, transfer, validation, and commercial supply.