16 days old

Sr. Manager, QC Analytical

Revance Therapeutics Inc.
Newark, CA 94560
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  • Job Code
    123514033
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The QC Sr. Manager of analytics will be responsible for improvement, development, implementation and maintenance of the analytical testing and stability programs. Areas of responsibility include management of the following programs within quality control; product testing, stability, raw materials, analytical method life cycle, and analytical laboratory/ processes and compliance. Job responsibilities include laboratory compliance to cGMPs and other relevant regulatory requirements and development, with implementation, of programs to maximize laboratory and staff efficiencies, testing and budgetary resourcing to support company goals within a regulated environment. The role is responsible for providing quality control oversight of Revance's third party contract testing laboratories.

Essential Duties/Responsibilities
  • Plan, organize and direct the activities related to QC Analytical and Stability Groups to ensure timely completion of tasks
  • Oversee the performance of group to ensure that products and processes meet company, regulatory and CDC requirements
  • Responsible for staffing, training and development of subordinates
  • Provide technical assistance and direction to the other CMC functional groups
  • Provide quality control oversight to contract testing laboratories
  • Lead the qualification, validation, and transfer of analytical methods for drug product, drug substance, customized materials, raw materials and in-process testing
  • Identify QC compliance gaps and work towards resolution in preparation of regulatory inspection. Interface with regulatory agencies during routine audits
  • Develop, direct and implement program and process update and upgrade to establish and maintain a satisfactory level of compliance with regulatory requirements
  • Direct the investigation of OOS and aberrant results in product and raw material testing. Resolves nature of the cause, impact, disposition, and corrective actions
  • Ensures the efficient use of resources to achieve department quality and operation plan objectives
  • Represent QC on cross-functional teams which address analytical issues and process improvements


Education

Minimum Required:

BS in Biochemistry, Chemistry or related Sciences

Preferred:

MS in related fields

Experience

Minimum Required:

10+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 4 of those years in QC management or leadership roles

Knowledge, Skills and Abilities

Minimum Required:
  • Proven strong interpersonal, organization and problem-solving skills
  • Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to Quality Control and method validation
  • Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment


Preferred:
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
  • Experience with developing and implementation of QC testing programs for biologics drug substance and injectable drug product in a commercial environment
  • Experience with preparing regulatory documentation and inspection management




PI123514033
Posted: 2020-09-10 Expires: 2020-10-12

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Sr. Manager, QC Analytical

Revance Therapeutics Inc.
Newark, CA 94560

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