19 days old

Sr. Director, Quality Assurance

Revance Therapeutics Inc.
Newark, CA 94560
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  • Job Code
    132437782
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The Sr Director QA is a key leader in the Quality Assurance department. The Senior Director, QA provides strategic direction and compliance guidance to QA staff and to the multidisciplinary CMC teams in accordance with US and ex-US GXP regulations. Manages all aspects of QA related to production, testing, and release of products for commercial distribution and clinical studies as needed. Provides guidance to and liaison with external third parties to ensure compliance with cGMP requirements. Selects, develops and mentors personnel.

This position is a technical leadership position requiring a balanced approach to developing, validating and executing cGMP operations and working in a collaborative manner with peers across other technical groups. The role requires high levels of GXP regulation knowledge.

Essential Duties/Responsibilities
  • Manage all aspects of quality assurance for production, testing, release of RM, DS, DP and customized materials manufactured in-house or by CMOs.
  • Manage QA personnel, and PQA budget including organizing and prioritizing group tasks, performing training, writing performance reviews and guiding personnel in longer-term development.
  • Manage competing priorities to meet departmental and organizational targets and timelines
  • Act as a high level technical resource for providing QA and guidance to QA Staff, Manufacturing, Facilities, Quality Control, Process Development, and R&D
  • Approve stability, test method, and method validation protocols and reports
  • Approve in-house and CMO manufacturing batch records, packaging and labeling records, and specifications
  • Ensure consistent quality standards across multiple contract manufacturers and testing laboratories
  • Prepare/execute Quality Agreements with third parties responsible for GMP manufacturing, testing, or distribution of products
  • Oversee Incoming QA of raw materials
  • Manage lot disposition activities in accordance with cGMP in a timely and compliant manner
  • Provide quality oversight for the labeling, packaging, storage, distribution of finished goods and clinical trial materials
  • Manage product complaints to resolution, and/or corrective action
  • Perform CMC section review of regulatory submissions
  • Lead Quality Review Boards
  • Lead cross-functional process improvements for BLA and commercialization readiness
  • Lead continuous improvement initiatives for PQA and QSC as needed
  • Oversee the technology transfer, including method transfer activities to third parties
  • Ensure site and GMP third party inspection readiness and interface with regulatory agencies as required
  • Host QP or other external audits, and co-host regulatory inspections of Revance as required


Education

Minimum Required:

Bachelor of Science degree in in biology, chemistry or related science

Experience

Minimum Required:
  • 15+ years of progressive experience in the biotechnology or pharmaceutical industry
  • 5+ years in related field at a senior level and leadership position


Knowledge, Skills and Abilities

Minimum Required:
  • Proven teamwork, management, with excellent interpersonal and communication skills. Demonstrated ability to negotiate.
  • Experience in cGMP requirements for various dosage forms, particularly injectable manufactured aseptically
  • Ability to manage multiple development and/or commercial projects
  • Solid and demonstrable knowledge and understanding of US and international (e.g. EU, ICH) cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of biologics/drugs produced for clinical use or market distribution.
  • Experience developing and organizing a team and respective budgets
  • Strong commitment to purpose and communication skills
  • Proven track record with marketing applications


Preferred:
  • Experience in GLP and GCP regulation sand clinical operations
  • Experience coordinating quality assurance activities between multiple contract and testing organizations
  • 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.




PI132437782
Posted: 2021-03-22 Expires: 2021-04-23

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Sr. Director, Quality Assurance

Revance Therapeutics Inc.
Newark, CA 94560

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