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Sr. Quality Manager

4 months ago

ParsippanyTroy Hills, United States TekWissen ® Full time

Position: Senior Manager

Location: Parsippany, NJ (preferred) or Foster City, CA

Duration: 6 Months

Job Type: Contract

Work Type: Hybrid

Pay Rate: $70-$78/hr


Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.


Job Description

Primary Responsibilities

  • Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with appropriate subject matter experts
  • Build, deploy and reinforce learning tools and materials to support quality event management capability development
  • Oversee the standard and timeliness of deviation and CAPA completion
  • Work with the business process owners to identify issues and improvement requirements and lead those improvement initiatives
  • In support of the quality management system module leads maintain records of issues, enhancement requests and support the implementation of system changes
  • Administer notification to management and escalation process
  • Participate in risk assessments and act as risk facilitator

Candidate Requirements

  • GxP experience is preferred
  • 10+ years experience in Biopharma experience
  • 6+ years managing investigations (deviations, CAPA, etc)
  • Experience writing investigations
  • Experience managing RCA
  • Self motivated

TekWissen® Group is an equal opportunity employer supporting workforce diversity.