Senior Quality Systems Lead - GMP & Inspections Ready

Andelyn Biosciences, Inc.; Columbus (OH); In loco; USD 110.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

401(k) Match

Paid Time Off

Descrizione del lavoro

Andelyn Biosciences in Columbus, OH, seeks a Senior Specialist, Quality Systems to lead and support the Quality Management System across GMP clinical and commercial manufacturing. You will partner with multiple functions to ensure compliance, efficiency, and inspection readiness.

The role emphasizes change control, risk management, and quality metrics, with strong emphasis on governance and continuous improvement.

Competenze

• Bachelor’s degree in Life Sciences, Engineering, or related field required.
• Minimum 8 years in GMP-regulated environment.
• Minimum 3–5 years in Quality Assurance/Quality Systems.
• Experience supporting clinical and commercial GMP manufacturing.
• Experience with internal, customer, and regulatory audits.

Mansioni

• Lead and support strategic Quality Systems initiatives, including QMS improvements and risk management.
• Coordinate Quality documentation, assessments, and compliance-related deliverables.
• Develop and maintain QMS procedures, workflows, and governance processes.
• Analyze metrics, trends, and KPIs to identify risks and improvement opportunities.
• Support audits, inspections, and readiness activities.

Conoscenze

Quality Systems

Change control

Risk management

Quality metrics

Audit support

Documentation

GMP knowledge

Project management

Formazione

Bachelor’s degree in Life Sciences or related field

Strumenti

Microsoft Office

Descrizione del lavoro

Andelyn Biosciences in Columbus, OH, seeks a Senior Specialist, Quality Systems to lead and support the Quality Management System across GMP clinical and commercial manufacturing. You will partner with multiple functions to ensure compliance, efficiency, and inspection readiness.

The role emphasizes change control, risk management, and quality metrics, with strong emphasis on governance and continuous improvement.