Quality Systems Specialist

Title:

Quality Systems Specialist About the Role

Support day-to-day execution and continuous improvement of Quality Management System (QMS) activities at the Thousand Oaks site. Serve as a Subject Matter Expert (SME) for assigned Quality System processes and partner with cross-functional teams (Manufacturing, Engineering, Validation, Automation, Laboratories, Maintenance, Metrology, Utilities, etc.) to strengthen processes and sustain compliance.

• Provide oversight and guidance for Change Controls, Deviations, CAPAs, Document Control, and Supplier Quality.
• Review, assess, and approve Deviations, CAPAs, Change Controls, and related quality documentation.
• Support continuous improvement of QMS processes (system updates, effectiveness assessments, compliance/data integrity improvements).
• Develop, revise, and maintain SOPs and other controlled documentation.
• Deliver Quality Systems training; mentor new QMS users.
• Build and maintain Quality Systems dashboards and reporting; analyze trends, risks, and improvement opportunities.
• Administer and serve as SME for electronic Quality Systems solutions.
• Support Supplier Quality (qualification, performance monitoring, resolution of supplier issues).
• Support audits/inspections (preparation, report development, response coordination, closure of observations).
• Promote quality culture and sustained compliance; act as point of contact/backup when needed; other duties as assigned.

• Bachelor’s in Science/Engineering or related field (strongly preferred).
• 5+ years Quality experience (required), preferably in regulated pharma/biotech.
• Knowledge of Quality Systems: nonconformance management, Change Control, CAPA, Document Control, Supplier Quality, product release (required).
• cGMP and Quality Systems requirements for pharma/biopharma operations (required).
• Strong PM/organizational/analytical skills; manage multiple priorities.
• Strong written/verbal communication; create/deliver presentations.
• Strong decision-making, interpersonal, and influencing skills.
• Advanced Excel (pivot tables, VLOOKUP/XLOOKUP, trend reporting, dashboards) (required).
• Preferred: quality process improvement tools; electronic QMS administration/SME; experience supporting audits/inspections/quality investigations/regulatory commitments; ability to identify and implement process improvements.