Senior QA Specialist, GxP & Data Integrity Expert

Revance; Newark (CA); Hybrid; USD 105,000 - 125,000; Full time

Job summary

Revance is seeking a Sr. Specialist, Quality Assurance in Newark, CA for hands-on QA within Quality Systems, focusing on lifecycle management of GxP facilities, instruments, and computerized systems, with collaboration across Quality Control, Manufacturing, IT, Supply Chain, and Regulatory Affairs.

The role offers a hybrid schedule (3 days in-office) with a salary range of $105,000-$125,000 plus annual bonus potential.

Qualifications

• Bachelor's degree required with 6+ years related experience.
• Experience in QA for pharma/biotech and familiarity with cGMP regulations.

Responsibilities

• Perform QA activities to ensure compliance with Revance procedures and regulatory requirements.
• Coordinate and close quality records including change controls, deviations, CAPAs, and investigations.
• Provide QA oversight for FUSE, AIQ, CSV/CSA and validation efforts per regulatory guidance.
• Oversee IT department quality footprint and system validation activities.
• Drive data integrity awareness and maintain Data Integrity Program across data lifecycle.
• Support quality metrics collection and continuous improvement of quality systems.
• Assist in internal audits and inspection readiness during regulatory reviews.

Skills

Quality assurance

Cross-functional teamwork

Verbal and written communication

Attention to detail

Data integrity

Regulatory compliance knowledge

Education

Bachelor's degree in Biology, Chemistry, or related science

Tools

21 CFR knowledge

ICH guidance familiarity

GxP systems software

Job description

Revance is seeking a Sr. Specialist, Quality Assurance in Newark, CA for hands-on QA within Quality Systems, focusing on lifecycle management of GxP facilities, instruments, and computerized systems, with collaboration across Quality Control, Manufacturing, IT, Supply Chain, and Regulatory Affairs.

The role offers a hybrid schedule (3 days in-office) with a salary range of $105,000-$125,000 plus annual bonus potential.