Quality Systems Site Lead – External Manufacturing

ACTalent; United States; Hybrid; USD 80,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Medical, dental & vision benefits

401(k) Retirement Plan

Job summary

Actalent is seeking a Quality Systems Specialist III for a hybrid role, onsite in Parsippany, NJ or Foster City, CA. You will serve as the Quality Site Lead, providing risk-based quality oversight across development, technology transfer, validation, launch, and commercial supply in a GMP-regulated environment.

You will build strong external quality governance, manage quality agreements, deviations, CAPAs, and change controls, and collaborate with cross-functional teams to ensure product quality

Qualifications

• Requires 5+ years in QA, QC, manufacturing or GMP-related function in biopharma/pharma.
• Experience applying GMP/regulatory standards to external operations and contracts.
• Strong ability to review change controls, deviations, CAPAs and quality agreements.

Responsibilities

• Provide risk-based quality oversight across development, tech transfer, validation, launch and commercial supply.
• Lead quality governance, track metrics, trends, audit outcomes and drive corrective actions.
• Coordinate quality agreements covering manufacturing, testing, disposition, change control, investigations and data governance.
• Support batch record review, release, disposition and issue resolution impacting product quality or supply continuity.
• Collaborate with Manufacturing, SCM, Regulatory CMC, Auditing and Quality Systems teams to implement quality and regulatory requirements.

Skills

Quality Assurance

GMP Compliance

Risk Management

Regulatory Liaison

Documentation Review

Education

Bachelor’s degree in science

Advanced degree preferred

Job description

Actalent is seeking a Quality Systems Specialist III for a hybrid role, onsite in Parsippany, NJ or Foster City, CA. You will serve as the Quality Site Lead, providing risk-based quality oversight across development, technology transfer, validation, launch, and commercial supply in a GMP-regulated environment.

You will build strong external quality governance, manage quality agreements, deviations, CAPAs, and change controls, and collaborate with cross-functional teams to ensure product quality