27 days old

Quality Engineering Manager, Quality Assurance

Revance Therapeutics Inc.
Newark, CA 94560
  • Job Code
    134006433
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The Quality Engineering Manager will be responsible for facilitating the investigation and execution of Quality Events across Revance, its CMO's and Alliance partners. The Manager will provide class leading, current, and science-driven support to the identification, execution and management of deviations, CAPA, complaints and other events as required.

This position is a technical operational position requiring broad knowledge of Manufacturing and Laboratory operations and will require working in a collaborative manner with others across other Departments and technical groups. The role requires good working knowledge of GMP regulation.

Essential Duties/Responsibilities
  • Serve as a competent QA Manager of the company, internally, within Alliance partners and with CMO's and to US FDA and other regulatory agencies to ensure Revance is appropriately represented in technical and compliance matters
  • Investigate, execute and facilitate Quality Events
  • Provide updates as required to Leadership
  • Utilize broad ranging manufacturing and laboratory knowledge to seek understanding of evens, root cause and appropriate CAPA
  • Establish and operate collaboratively across Revance and where required CMOs and Alliance partners.
  • Be part of the team that establishes excellence in Quality Assurance standards and execution across Revance
  • Work well with a team and collaboratively across areas outside lines of responsibility
  • Ensure compliance with applicable ICH guidelines and global regulations
  • Ensure adherence to GXPs
  • Provide support for regulatory submissions
  • Train other qualified staff to ensure effective execution of roles and responsibilities


Education

Minimum Required:
  • Bachelor of Science degree in sciences/engineering


Preferred:
  • M.S in relevant scientific discipline such as biochemistry, chemistry, pharmaceutical sciences or related filed


Experience

Minimum Required:
  • 5+ years of progressive experience in the biotechnology or pharmaceutical industry
  • Experience of working in a GMP laboratory or Aseptic Manufacturing Facility
  • Experience of investigating and facilitating events management in a GMP environment


Knowledge, Skills and Abilities

Minimum Required:
  • Hands on experience of QMS Events in a GMP environment
  • General laboratory or Manufacturing Experience
  • GXP regulatory experience
  • Experience writing, reviewing and driving root cause and capa for Quality Events such as deviations
  • Experience liaising with and providing information to Leadership
  • Commitment to purpose and good communication skills


Preferred:
  • Have experience of supporting and defending event write ups and decisions during regulatory inspection.
  • Be able to communicate technically and strategically across technical and operational activities and work collaboratively across the business to ensure successful execution
  • Possess excellent communication skills
  • Be a self-confident, proactive and driven QA practitioner






PI134006433

Categories

Posted: 2021-04-13 Expires: 2021-05-14

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Quality Engineering Manager, Quality Assurance

Revance Therapeutics Inc.
Newark, CA 94560

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