Quality Program Manager II: Batch Release & Compliance Lead

Curia Aalborg ApS; Albuquerque (NM); Vor Ort; USD 97.000 - 119.000; Vollzeit

Zusammenfassung

Curia Global Inc. in Albuquerque, NM is seeking a Quality Program Manager II to join the quality management team.

The role ensures effective execution of quality programs under cGMP regulations and interfaces with CURIA-Albuquerque customers to manage quality activities and batch release processes. The position collaborates with the Director of Quality Operations to support continuous improvement, identify risks, and drive initiatives to enhance product quality and operational performance.

Qualifikationen

• Qualified graduate with strong QA background in cGMP environments.
• Experience coordinating batch reviews and product disposition under timelines.
• Familiarity with FDA inspections and internal audits.

Aufgaben

• Acts as the primary QA contact for CURIA-Albuquerque clients and oversees batch release reviews.
• Ensures batch records are thoroughly reviewed before disposition to customers.
• Closes Deviations, CAPAs, Change Controls, and Customer Complaint Investigations.

Kenntnisse

Quality management

cGMP experience

Deviation/CAPA management

Batch release handling

Ausbildung

Master’s degree in Regulatory Affairs or related field

FDA certification in Risk Management

FDA certification in Drug Surveillance

FDA certification in Manufacturing and Product Quality

Jobbeschreibung

Curia Global Inc. in Albuquerque, NM is seeking a Quality Program Manager II to join the quality management team.

The role ensures effective execution of quality programs under cGMP regulations and interfaces with CURIA-Albuquerque customers to manage quality activities and batch release processes. The position collaborates with the Director of Quality Operations to support continuous improvement, identify risks, and drive initiatives to enhance product quality and operational performance.