Curia · 3 days ago
Manager, Quality Systems
Albuquerque, NM
Full-time
Onsite
Mid, Senior Level
5+ years expCuria is a global contract development and manufacturing organization (CDMO) focused on providing life-saving treatments. The Quality Systems Manager leads a team responsible for ensuring quality and compliance in the manufacturing of parenteral sterile drug products, developing and improving quality systems, and managing quality events and audits.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
Bachelor's degree 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
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
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Preferred
Minimum of five (5) years' experience in a cGMP-regulated manufacturing Pharmaceutical, or Biotechnology environment, preferred
Experience with process improvement and Continuous Improvements (CI) methodologies such as Lean, Six Sigma, or Kepner-Tregoe problem solving, preferred
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
And more!
Company
Curia
Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.
1001-5000 employees
H1B Sponsorship
Curia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2025-03-07Debt Financing
2017-08-31Private Equity
Leadership Team
Steve Lavezoli
Vice President, Biologics Division
Recent News
2025-10-31
thecanadianpressnews.ca
2025-10-29
Curia Global, Inc.
2025-10-27
Company data provided by crunchbase