QA Compliance Leader — Regulated Manufacturing (Philly Area)

i‑Pharm Consulting; Philadelphia (Philadelphia County); Vor Ort; USD 99.000 - 121.000; Vollzeit

Zusammenfassung

i‑Pharm Consulting seeks an experienced Quality Assurance Manager to lead quality systems, regulatory compliance, and product quality oversight in a regulated manufacturing environment near Philadelphia, PA. You will manage QA operations and supervise QA personnel while partnering with operations, technical teams, and regulatory authorities to drive compliance and continuous improvement.

The role focuses on ensuring timely product release, audit readiness, CAPA management, and continuous

Qualifikationen

• Bachelor’s degree in a related scientific field and 5+ years QA in a regulated manufacturing environment.
• Proven leadership experience with direct responsibility for QA personnel.
• Strong knowledge of GMP regulations and product release processes.
• Experience supporting regulatory inspections and external audits.
• Experience managing deviations, investigations, CAPAs, change controls, and validation activities.

Aufgaben

• Provide leadership for QA activities across manufacturing, quality systems, and product release.
• Serve as primary QA representative for customers and cross-functional teams.
• Review and approve batch documentation and final product disposition.
• Lead internal and external audits, CAPA management, and deviation handling.
• Drive continuous improvement and regulatory readiness across QA functions.
• Support regulatory submissions and technical documentation as required.

Kenntnisse

Leadership

GMP knowledge

Regulatory audits

CAPA management

Quality systems

Documentation control

Ausbildung

Bachelor’s degree in Chemistry/ Biology/ Chemical Engineering/ Pharmaceutical Sciences

Tools

GMP systems

QMS software

Electronic documentation

MS Office

Jobbeschreibung

i‑Pharm Consulting seeks an experienced Quality Assurance Manager to lead quality systems, regulatory compliance, and product quality oversight in a regulated manufacturing environment near Philadelphia, PA. You will manage QA operations and supervise QA personnel while partnering with operations, technical teams, and regulatory authorities to drive compliance and continuous improvement.

The role focuses on ensuring timely product release, audit readiness, CAPA management, and continuous