Quality Program Manager II

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

Job Description

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.

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.

Requires a Master’s degree in Regulatory Affairs or a related field. The successful candidate must also have FDA certification in Risk Management and Drug Surveillance and FDA certification in Manufacturing and Product Quality.

Salary Amount/Range $108,202./year.