QMS Strategy Director — Quality Systems & Change Leader

Exelixis, Inc.; Alameda (CA); Sur place; USD 176 000 - 251 000; Plein temps

Avantages offerts par ce poste

401k plan

Medical/Dental/Vision

Stock options

Discretionary bonus

Paid time off: 15 days

Holidays: 17

Sick leave: 10 days

Résumé du poste

Exelixis, Inc. seeks an Associate QA Systems and Process QMS Director to lead quality management systems, drive cross-functional QMS improvements, and ensure compliant handling of deviations, CAPAs and change controls.

You will own Veeva QMS enhancements, coordinate with IT, RA, PSC, and operations, and prepare metrics and inspections readiness with a strong focus on risk-based quality and continuous improvement.

Qualifications

• BS/BA in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline with 11 years of related experience.
• MS/MA in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline with 9 years of related experience.
• Equivalent combination of education and applicable experience.
• Experience in pharmaceutical or biotech industries and Quality Systems preferred.

Responsabilités

• Champion QA support for QMS including Deviations, Change Control, CAPA and Effectiveness checks.
• Owns business process for eQMS and provide guidance on QMS use and records.
• As Change Control Process owner, drive cross-functional compliance and timely quality records.
• Own governing procedures and drive continuous improvement of QMS processes.
• Provide monthly Veeva Quality event status reports to QA and functions.

Connaissances

Communication

Time management

Change management

Regulatory knowledge

Problem solving

Cross-functional collaboration

Leadership without authority

Formation

BS/BA in Biology, CS, Education or related

MS/MA in Biology, CS, Education or related

Outils

Veeva Quality Management

CSV tooling

Description du poste

Exelixis, Inc. seeks an Associate QA Systems and Process QMS Director to lead quality management systems, drive cross-functional QMS improvements, and ensure compliant handling of deviations, CAPAs and change controls.

You will own Veeva QMS enhancements, coordinate with IT, RA, PSC, and operations, and prepare metrics and inspections readiness with a strong focus on risk-based quality and continuous improvement.