25 days old

Associate Director, Quality Assurance

Revance Therapeutics Inc.
Newark, CA 94560
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  • Job Code
    122973212
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The role is responsible for providing quality assurance management support to the cross-functional CMC teams and ensuring compliance with cGMP requirements (US and EU), in-house SOPs and standards for Revance clinical and commercial products. Furthermore, the role is responsible for providing quality management oversight to Revance's third party contractors and alliance partners as required.

Essential Duties/Responsibilities
  • Provide quality assurance oversight for production, environmental monitoring, testing and release of materials manufactured in-house or by CMOs / Alliance partners.
  • Develop, implement and maintain programs and processes to ensure high quality products and compliance with cGMPs
  • Manage a team to organize and prioritize group tasks, provide job skills training and mentoring of personnel
  • Review and approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, sampling plans, test methods, specifications, and protocols and reports for method validations and stability studies
  • Act as a compliance resource to provide guidance and assistance around aseptic processing and towards resolution of complex deviations, quality investigations, lab investigations, CAPAs and change control; review and approve quality system documents related to manufactured products
  • Ensure consistent quality standards across all areas of responsibility
  • Responsible for QA reserve sample management
  • Conducts and/or mentor staff to perform product complaints investigations
  • Participates in Quality Review Board meetings
  • Develop, continuously improve and maintain product quality assurance performance metrics and department databases
  • Support regulatory agency inspections or third party audits by participating in inspection preparation and assisting the inspection strategy room


Education

Minimum Required:

BA or equivalent in biology, chemistry or related science

Preferred:

MS or PhD

Experience

Minimum Required:

Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry with at least 7 of those years in QA or closely related field and at least 5 years in management and/or supervisory role

Preferred:

Comprehensive expertise and working knowledge of 21 CFR Parts 201, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents

Knowledge, Skills and Abilities

Minimum Required:
  • Excellent interpersonal and verbal and written communication skills
  • Experience in aseptic processes is highly desirable and knowledge of biologics is a plus
  • Ability to manage multiple projects; from clinical to commercial operations
  • Excellent working knowledge and understanding of US cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of biologics/drugs produced for clinical trial investigation and marketed products
  • 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
  • Prior experience with regulatory inspections




PI122973212
Posted: 2020-08-26 Expires: 2020-09-27

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Associate Director, Quality Assurance

Revance Therapeutics Inc.
Newark, CA 94560

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