Quality Systems Specialist
Takeda
August 20, 2026
On-site
Thousand Oaks, CA
$89,900 - $141,240 USD yearly
Operations
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.
Application Instructions
- Apply via the “Apply” button.
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.
Application Instructions
- Apply via the “Apply” button.