Quality Program Manager II

Curia•Albuquerque, NM

About The Position

Curia Global Inc. is hiring a Quality Program Manager II in Albuquerque, New Mexico. This mid-level member of the quality management team is responsible for effective execution of quality programs within cGMP regulations. The role interfaces with internal and external stakeholders, including CURIA-Albuquerque customers, to manage quality-related activities, resolve issues, and facilitate batch release according to customer and regulatory requirements. The Quality Program Manager II collaborates closely with the Director of Quality Operations on continuous improvement, risk identification, and initiatives to improve product quality and operational performance. The role manages customer quality expectations, partners with cross-functional teams to resolve quality issues, and ensures timely resolution of deviations and CAPAs. It also contributes to developing and refining processes to meet changing 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 customers and within established timelines.
Close 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 uphold 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 a subject matter expert on 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 training.
Perform other duties as assigned.