Senior Quality Assurance Specialist

About the role

The Sr. Specialist, Quality Assurance is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will work in the Quality Systems team to provide quality oversight across the lifecycle management of GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems, and support maintenance of the company’s Data Integrity Program. This role interacts with cross-functional groups including Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs.

Responsibilities

• Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures and applicable US and international regulatory requirements for biologic drug substances and drug products.
• Coordinate and track closure of quality records such as change controls, deviations, CAPAs, and quality investigations.
• Provide quality oversight for Facilities/Utility System/Equipment (FUSE) Qualification, Analytical Instrument Qualification (AIQ), and Computerized Systems Validation/Assurance (CSV/CSA), applying risk-based methodology in accordance with current regulatory requirements and industry guidance.
• Provide quality oversight of the Information & Technology (IT) Department.
• Provide quality oversight of steady state activities including System Audit Trail Reviews, User Account Maintenance, and Periodic Reviews, as well as quality records (deviations, CAPAs, and change controls) for GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems.
• Drive data integrity awareness and maintain the Data Integrity Program to ensure compliance and reliability across the data lifecycle for GxP Operations.
• Support the development, collection, and management of quality metrics to optimize performance, productivity, and effective resource planning.
• Support continuous improvement of quality systems by authoring new or revising existing department procedures and/or forms.
• Assist in internal compliance audits as needed.
• Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.

Requirements

• BS or equivalent in biology, chemistry or related science, or equivalent experience.
• Minimum of 6 years of experience in the pharmaceutical or biotechnology industry, with at least 4 of those years in QA or a closely related field.
• Good working knowledge of 21 CFR Parts 201, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
• Good interpersonal, verbal, and written communication skills.
• Experience in aseptic processes is highly desirable and knowledge of biologics is a plus.
• Ability to manage multiple clinical projects.
• Good working knowledge and understanding of US and international (e.g., EU, ICH) cGMP regulations, procedures, and guidelines governing manufacturing, quality control, and quality assurance of biologics/drugs produced for clinical trial investigation.
• Attention to detail with an ability to perform critical review of various types of technical documents.
• Proficient with commonly used word processing, database systems, and other software.

Benefits

• Competitive compensation including base salary and annual performance bonus.
• Flexible PTO (12 days’ PTO), holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer-paid life and disability insurance, pet insurance, wellness discounts and more.

Pay

Salary range: $105,000–$125,000 plus annual bonus potential; final salary offered will depend on factors including quality and length of experience, education, and geographic location.

Schedule

Newark, CA – hybrid schedule (3 days in office).