Manager, Quality Systems

Job Description

Manager, Quality Systems – Albuquerque, NM – Curia

Build your future at Curia, where our work has the power to save lives.

The Quality Systems Manager leads a team that is responsible for ensuring the highest standards of quality and compliance in the manufacturing of parenteral sterile drug products. This role involves developing, implementing, and continuously improving comprehensive quality systems that adhere to regulatory requirements and industry best practices.

This position will be responsible for managing Quality Events (Deviations, Out‑of‑Specification), Corrective and Preventive Actions (CAPA), and Change Control processes. The manager will lead investigations ensuring effective and timely CAPA. Additionally, they will support internal and customer audits and regulatory inspections. Supporting quality management reviews, administering department training programs, and utilizing electronic Quality Management Systems (eQMS) such as Track Wise are also crucial aspects of this role.

• Oversee the site’s change control program, ensuring quality review and approval of changes related to documents, equipment, facilities, utilities, materials, products, computer systems, quality systems, regulatory submissions, calibration, and validation.
• Oversee the site’s Quality Event and CAPA programs, ensuring quality review and approval of related records.
• Chair the site’s Quality System Review Boards and host cross‑functional committee meetings to review complex changes and investigations, assuring there is no impact to product quality or validated status.
• Act as the subject matter expert for quality system compliance with procedural and regulatory requirements.
• Develop and deliver training for processing Quality System records in the Track Wise Digital Information Management system, and serve as the primary quality contact.
• Review and approve due date extension requests as needed.
• Develop and author local Quality System procedures and forms tailored to the Albuquerque site while adhering to corporate procedures.
• Maintain records according to cGMPs.
• Provide oversight for the site’s Quality System program, ensuring timely quality review and approval of records and managing the performance and metrics of the systems.
• Support the Quality Management Review program, reporting monthly and quarterly metrics/KPIs to site leadership related to the Quality System.
• Drive continuous improvement projects through the CAPA process, collaborating with management and CAPA Process Owners to ensure effective corrective and preventive actions.
• Participate in on‑site customer and regulatory agency inspections (e.g., FDA, EMA, PMDA, CFDA), presenting quality systems information and supporting backroom activities.
• Interpret and revise SOPs to ensure cGMP compliance.
• Maintain up‑to‑date training.
• Other duties as assigned.

• Bachelor’s degree in Science, Chemistry, Biology, or a related field of study.
• Minimum of five (5) years’ experience in Quality Systems or related work.
• Minimum of five (5) years’ experience in a cGMP‑regulated manufacturing pharmaceutical or biotechnology environment (preferred).
• Minimum of two (2) years in a leadership role.
• Experience with U.S. FDA and EMEA regulations.
• Experience with process improvement and Continuous Improvements (CI) methodologies such as Lean, Six Sigma, or Kepner‑Tregoe problem solving (preferred).

This role is responsible for leading and supporting a team, overseeing day‑to‑day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. The role also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

• Must pass a background check.
• Must pass a 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.

The essential physical…