Manager, Quality Systems

Curia • Albuquerque, NM

10d

About The Position

Description Manager, Quality Systems in Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. We proudly offer: Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401k program Learning platform And more! Summary: 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 Corrective and Preventive Actions (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 TrackWise are also crucial aspects of this role.

Requirements

• Bachelor’s degree in in Science, Chemistry, Biology or related field of study
• Minimum of five (5) years’ experience in Quality Systems or relevant 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
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Experience with process improvement and Continuous Improvements (CI) methodologies such as Lean, Six Sigma, or Kepner-Tregoe problem solving, preferred
• May be required to obtain and maintain media qualification
• May be required to wear a respirator

Responsibilities

• 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 Corrective and Preventive Actions (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 TrackWise 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
• Supporting 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 trainings
• Other duties as assigned

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees