Associate Director, Quality Risk Management

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 04/02/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

Job Summary

  • The position will establish and lead CRISPR’s Quality Risk Management group. 
  • The position will act as the Risk Champion and system owner for the CRISPR Quality Risk Management program and processes
  • This group will support all functions across CRISPR, including Quality, Operations, and IT.
  • Primary responsibilities are focused on providing overall leadership and direction for CRISPR’s risk management and business continuity efforts to help our sites (internal and external) achieve the changes required to develop and embed risk management as a core business and operational process for CRISPR.

Responsibilities

  • Act as primary lead to help CRSP develop and embed risk management as a core business and operational process, implementing a set of risk indicators, reports, and identifying key risk exposures and early warning indicators.
  • Ensure Quality representatives are assigned for all formal Risk Assessment teams at CRISPR.
  • Ensure that the Risk Management program at CRSP is compliant with corporate policies and procedures as well as current regulatory requirements and industry best practices
  • Ensure that Risk Assessments meet the requirements of CRISRP standards and procedures, are clearly written, and appropriately justified.
  • Ensure that Risk Assessment records are controlled and managed in a compliant manner throughout their life cycle including storage and archiving, and that the record control system meets the requirements of CRISPR’s procedures. Track, oversee and monitor Risk Assessment records at various points in their life cycle, utilizing compliant tracking tools.
  • Provides guidance to Quality, Operations, IT, and other departments regarding the proper use of the Risk Assessment tools and the risk management process.
  • Ensure that key users of the Quality Risk Management systems are appropriately trained in regulations and SOPs.
  • Provide mentoring and guidance to users on the Quality Risk Management system, its compliance, and regulatory requirements. Monitor performance of the risk facilitators.
  • Monitor the status of open Risk Assessments, providing periodic reports and status updates on the overall performance of the Risk Management program.
  • Propose and implement modifications to the Risk Management Program to improve compliance, efficiency, and customer satisfaction.  Provides timely support to continuous improvement initiatives across the site and the network.
  • Provides support and defend the Quality Risk Management system during internal and external audits, as necessary.
  • Create and maintain the site Risk Management Plan, and that risk assessment reviews are performed in accordance with the Plan.
  • Work with individual system owners to identify and deploy Risk facilitators for formal risk assessments. ·
  • Communicate risks to the appropriate stakeholders including the Site Risk Profile Report author, and escalates compliance risks as needed, and proposes countermeasures for identified adverse trends.
  • Establish and maintain CRSP Program Risk Registers to ensure all risks are appropriately ranked, assessed, and mitigated as necessary.

Minimum Qualifications

  • Master's Degree and 8 years of relevant experience; or bachelor’s degree and 10 years of relevant experience; or associate degree and 12 years of relevant experience.
  • 6 years of relevant experience AND 5 years of experience in Risk Management related to Quality support for ongoing GMP manufacturing operations

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.