QA Investigations, CAPA & Change Control Supervisor

Revance Therapeutics, Inc.; Johnson City (TN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Flexible PTO

Healthcare benefits

HSA and 401(k) matching

Parental leave

Wellness discounts

Pet insurance

Job summary

Revance Therapeutics, Inc. is seeking a Quality Assurance Supervisor focused on investigations, CAPA, and change control at the Johnson City, TN site. This role ensures adherence to FDA/ICH standards, drives thorough investigations, and implements sustainable CAPAs.

The supervisor will collaborate with Manufacturing, QA, Validation, and Supply Chain to maintain data integrity and regulatory readiness while guiding QA personnel on investigation techniques and documentation.

Qualifications

• Bachelor's degree in life sciences, engineering, or related field required.
• Minimum 5 years of QA experience in a cGMP-regulated environment (pharma, OTC, or medical device).
• Experience managing deviations, CAPAs, and change control systems.
• FDA inspections and regulatory audits experience preferred.
• Proficiency with 21 CFR Parts 210, 211, 11, ICH Q7–Q10 and USP chapters.
• Root cause analysis tools and Six Sigma methodologies.
• Experience with eQMS such as MasterControl, Veeva, or ETQ Reliance.
• Familiarity with data integrity and ALCOA+ principles.

Responsibilities

• Lead investigations and root-cause analysis for deviations and nonconformances.
• Oversee CAPA lifecycle from creation through verification of effectiveness.
• Manage change control activities including regulatory impact and risk assessment.

Skills

Investigations & root cause analysis

CAPA management

Change control management

Data integrity & ALCOA+

Six Sigma methodologies

eQMS familiarity

Education

Bachelor's degree in Life Sciences, Engineering, or related field

Tools

MasterControl

Veeva

ETQ Reliance

Job description

Revance Therapeutics, Inc. is seeking a Quality Assurance Supervisor focused on investigations, CAPA, and change control at the Johnson City, TN site. This role ensures adherence to FDA/ICH standards, drives thorough investigations, and implements sustainable CAPAs.

The supervisor will collaborate with Manufacturing, QA, Validation, and Supply Chain to maintain data integrity and regulatory readiness while guiding QA personnel on investigation techniques and documentation.