Quality Program Manager II

Curia • Albuquerque, NM

8h

About The Position

The Quality Program Manager II is a mid-level member of the quality management team responsible for effective execution of quality programs within the framework of cGMP regulations. The position interfaces with internal and external stakeholders, including CURIA-Albuquerque customers, to manage quality activities, resolve issues, and facilitate batch release in accordance with customer and regulatory requirements.

Working closely with the Director of Quality Operations, the role supports continuous improvement, identifies potential risks, and drives initiatives to improve product quality and operational performance. It manages customer quality expectations, works with cross-functional teams to resolve quality issues, and ensures timely resolution of deviations and CAPAs. The position also contributes to developing and refining processes to meet evolving business needs while maintaining compliance with internal and external quality standards.

Requirements

• Master’s degree in Regulatory Affairs or a related field.
• FDA certification in Risk Management and Drug Surveillance.
• FDA certification in Manufacturing and Product Quality.

Responsibilities

• Act as the primary quality assurance contact for CURIA-Albuquerque clients.
• Ensure batch records are thoroughly reviewed before product disposition to the customer within established timelines.
• Ensure closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-Albuquerque client products.
• Coordinate with other CURIA-Albuquerque departments to maintain operational partnerships and support quality standards and regulatory compliance.
• Support the CURIA-Albuquerque Compliance department during FDA and other agency inspections, as well as customer and internal audits.
• Present project updates to internal and external stakeholders.
• Provide additional quality assurance support and functions as specified by the Director of Quality Operation.
• Act as the subject matter expert for quality issues related to batch release.
• Help drive continuous quality improvement initiatives.
• Provide sitewide quality training related to batch review.
• Read and interpret SOPs to ensure compliance.
• Maintain up-to-date trainings.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level