Quality Program Manager II

Curia • Albuquerque, NM

12h

About The Position

The Quality Program Manager II is a mid-level member of Curia’s quality management team, responsible for executing quality programs within cGMP regulations. The role serves as a quality interface 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 Quality Program Manager II supports continuous improvement, identifies potential risks, and advances initiatives to improve product quality and operational performance. The role manages customer quality expectations, coordinates 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 business needs while maintaining compliance with internal and external quality standards. The position has no supervisory responsibilities, though it may involve mentoring, guiding, and advising others.

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 and drug screen.
• May be required to pass Occupational Health Screening.
• May be required to obtain and maintain media qualification.
• May be required to wear a respirator.

Nice To Haves

• At least two years of experience in a quality position is preferred.
• Demonstrates business acumen.
• Leads with integrity and respect; fosters a collaborative and positive work environment; champions change; and coaches and develops others.

Responsibilities

• Act as the primary quality assurance contact for Curia-Albuquerque clients.
• Ensure batch records are thoroughly reviewed before product disposition to the customer and within established timelines.
• Close deviations, CAPAs, change controls, and customer complaint investigations related to Curia-Albuquerque client products.
• Interface with other Curia-Albuquerque departments to maintain operational partnerships and ensure 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 perform functions specified by the Director of Quality Operations.
• 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 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.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

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