QMS Director: Quality Systems & Process Improvement

Exelixis Inc; Alameda (CA); On-site; USD 176,000 - 251,000; Full time

Benefits offered by this job

401k plan

Medical, dental, vision

Life and disability insurance

Stock purchase plan

Paid holidays and vacation

Bonus program

Job summary

Exelixis Inc seeks an Associate QA Systems and Process QMS Director to lead quality management systems and drive compliant, timely execution of quality events. You will partner with QA and cross-functional teams to enhance eQMS and CSV processes, and to ensure robust risk management and record integrity.

The role requires deep knowledge of cGMP, regulatory expectations and the ability to drive continuous improvement across the organization, including preparation for inspections and metrics

Qualifications

• Bachelor’s or Master’s degree in a related field with extensive QA/quality systems experience.
• Pharma/biotech industry experience with Quality Systems preferred.
• Knowledge of cGMPs and Health Authority Regulations.

Responsibilities

• Provide QA leadership for QMS including Deviations, Change Control, CAPA, and Effectiveness checks.
• Own eQMS business processes and guide best practices for record completeness.
• Oversee Veeva enhancements and ensure timely quality records.
• Develop and implement risk-based QMS strategies across GxP.

Skills

Quality management

cGMP knowledge

Regulatory inspections

Cross-functional leadership

Data analysis

Change control

QMS governance

Process improvement

Education

BS/BA in Biology or related

MS/MA in Biology or related

Tools

Veeva

eQMS

Job description

Exelixis Inc seeks an Associate QA Systems and Process QMS Director to lead quality management systems and drive compliant, timely execution of quality events. You will partner with QA and cross-functional teams to enhance eQMS and CSV processes, and to ensure robust risk management and record integrity.

The role requires deep knowledge of cGMP, regulatory expectations and the ability to drive continuous improvement across the organization, including preparation for inspections and metrics