Quality Program Manager II
Curia
Summary
Curia Global Inc. (Albuquerque, NM) Quality Program Manager II. Key member of the quality management team, responsible for ensuring the effective execution of quality programs within the framework of cGMP regulations. This mid-level role interfaces with internal and external stakeholders, including CURIA-Albuquerque customers, to manage quality-related activities, resolve issues, and facilitate batch release processes in accordance with customer and regulatory requirements.
Job description
The Quality Program Manager II collaborates closely with the Director of Quality Operations to support continuous improvement efforts, identify potential risks, and drive initiatives aimed at enhancing product quality and operational performance. This role is also tasked with managing customer quality expectations, working with cross-functional teams to resolve quality issues, and ensuring the timely resolution of deviations and CAPAs. The Quality Program Manager II will contribute to developing and refining processes to meet the evolving needs of the business while ensuring compliance with both internal and external quality standards.
Specifically, the Quality Program Manager II will perform the following duties:
- Acts as the primary quality assurance contact for CURIA-Albuquerque clients
- Responsible for ensuring batch records have been thoroughly reviewed before product disposition to the customer within established timelines
- Responsible for closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-Albuquerque client products
- Interfaces with the other CURIA-Albuquerque departments to communicate and maintain a partnership necessary for on-going operations and ensure the highest quality standards and regulatory compliance
- Supports CURIA-Albuquerque Compliance department during FDA and other agency inspections as well as customer and internal audits
- Presents project updates to internal and external stakeholders
- Provides all additional quality assurance support and functions as specified by the Director of Quality Operation
- Will act as subject matter expert for all quality issues related to batch release
- Will help drive continuous quality improvement initiatives
- Will provide quality training related to batch review, sitewide
- Read/interpret SOPs to ensure compliance
- Maintain up to date trainings
- Other duties as assigned
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
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.