Quality Systems Specialist

Scorpion Therapeutics; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics is seeking a Quality Systems Specialist to drive day-to-day QMS activities at the Thousand Oaks site. You will serve as SME for Quality System processes and partner with cross-functional teams to strengthen processes and maintain compliance.

You will oversee change controls, deviations, CAPAs, document control, and supplier quality while developing SOPs, dashboards, and training materials. Strong Excel skills and pharma/biotech experience are required.

Qualifications

• 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; audits/inspections/quality investigations/regulatory commitments; process improvements.

Responsibilities

• 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.

Skills

Quality Systems

Change Control

CAPA

Document Control

Supplier Quality

GxP

Data Integrity

Advanced Excel

Communication

Education

Bachelor's degree in Science/Engineering

Tools

Electronic QMS

Job description

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.

How You Will Contribute

• 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.

What You Bring

• 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.