Quality Program Manager II

Curia•Albuquerque, NM

11d

About The Position

The Quality Program Manager II is a mid-level member of Curia’s quality management team, responsible for effective execution of quality programs within cGMP regulations. The role serves as the primary quality assurance contact for CURIA-Albuquerque clients and works with internal and external stakeholders to manage quality activities, resolve issues, and facilitate batch release in accordance with customer and regulatory requirements. The position collaborates with the Director of Quality Operations and cross-functional teams to manage customer quality expectations, support continuous improvement, identify risks, and ensure timely resolution of deviations and CAPAs. It also supports the development and refinement of processes to meet evolving business needs while maintaining compliance with internal and external quality standards. The position has no supervisory responsibilities but may mentor, guide, and advise team members.

Requirements

Bachelor’s degree in Science or a related field of study.
At least three years of GMP experience in an FDA-regulated pharmaceutical environment.
Strong attention to detail.
Ability to work promptly and under pressure to meet customer and business deadlines associated with batch-record lot release.
Must pass a background check.
Must pass a drug screen.

Nice To Haves

At least two years of experience in a Quality position is preferred.
May be required to pass Occupational Health Screening.
May be required to obtain and maintain media qualification.
May be required to wear a respirator.
Experience, education, location, and tenure may be considered along with internal equity when job offers are extended.

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.
Ensure closure of Deviations, CAPAs, Change Controls, and Customer Complaint Investigations related to CURIA-Albuquerque client products.
Coordinate with other CURIA-Albuquerque departments to support ongoing operations, partnership, quality standards, and regulatory compliance.
Support the Compliance department during FDA and other agency inspections, customer audits, 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 Operations.
Serve as the subject matter expert for quality issues related to batch release.
Help drive continuous quality improvement initiatives.
Provide quality training related to batch review and sitewide requirements.
Read and interpret SOPs to ensure compliance.
Maintain up-to-date training.
Provide guidance, coaching, and mentorship to team members sitewide.
Promote a safe and healthy work environment by identifying and addressing potential hazards, following safety protocols, participating in safety training, and fostering awareness and responsibility.
Perform other duties as assigned.