Senior Quality Systems Manager - GMP & FDA Compliance

Catalent, Inc.; Lawrenceburg (IN); In loco; USD 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive PTO

Medical, dental, vision benefits

Tuition Reimbursement

Site engagement activities

Descrizione del lavoro

Catalent, Inc. in Greendale, IN is seeking a Senior Manager of Quality Systems to lead the Quality and Compliance functions onsite.

You will supervise QA Supervisors and Specialists, ensuring operational quality, testing, and product release meet stringent regulatory standards. You will collaborate with cross-functional teams to maintain product integrity, drive continuous improvement, and ensure timely supplier and customer satisfaction while maintaining rigorous FDA, NSF, and SQF compliance

Competenze

• Bachelor’s degree in science or related field with 5+ years in pharmaceutical/dietary supplement quality.
• 7+ years of related experience, including 3–4 years in supervision.
• GMP compliance experience in pharma/dietary supplement.
• Ability to work under pressure; sit/stand; lift up to 15 pounds.
• Catalent leadership program experience may count in place of external experience.

Mansioni

• Oversee Quality and Compliance functions for dietary supplement manufacturing.
• Lead QA Supervisors and Specialists for release and testing.
• Review change controls, formulations, label changes, deviations, CAPA, and complaints.
• Ensure FDA, NSF, SQF compliance and participate in audits.
• Develop and maintain quality policies, procedures, and guidelines.
• Drive continuous improvement in quality and efficiency.

Conoscenze

Quality leadership

Regulatory compliance

GMP experience

Audit readiness

Cross-functional collaboration

Root cause analysis

Formazione

Bachelor’s degree in science

Strumenti

JDE

TrackWise

Quality Management System

Veeva

Compliance Wire

Stability Programs

LMS

Descrizione del lavoro

Catalent, Inc. in Greendale, IN is seeking a Senior Manager of Quality Systems to lead the Quality and Compliance functions onsite.

You will supervise QA Supervisors and Specialists, ensuring operational quality, testing, and product release meet stringent regulatory standards. You will collaborate with cross-functional teams to maintain product integrity, drive continuous improvement, and ensure timely supplier and customer satisfaction while maintaining rigorous FDA, NSF, and SQF compliance