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Associate Director, QA Operations

Company: CRISPR Therapeutics AG
Location: Cambridge
Posted on: June 7, 2021

Job Description:

Company Overview

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

Reporting to the Sr. Director of GMP Quality, the position provides Quality oversight of the development, manufacture, and distribution of clinical products. This role is responsible for ensuring the company, its affiliates and/or contractors associated with manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and applicable regulations. This position will require up to 20% domestic and international travel.

Responsibilities

  • Primary CRISPR Quality contact for external contract manufacturing and testing laboratories
  • Responsible for Quality oversight of CRISPR activities performed at third party sites, including business review meetings and on-site visits.
  • Responsible for release of starting materials, intermediates, drug product and finished goods
  • Lead GMP investigations, CAPA, and change management actions
  • Responsible for Quality Support required to complete CMC sections of regulatory submissions
  • Assist in the development of the CRISPR Quality Management System, including maintaining and reviewing metrics to monitor performance.
  • Support GMP supplier qualification by assisting with audits and development of Quality Agreements
  • Represent the QA department on CMC and Joint Project Teams
  • Foster CRISPR Therapeutics Core Values when collaborating with cross functional teams and external partners

Qualifications

  • BS in Biological Sciences, Analytical Chemistry, Chemical Engineering, or related fields
  • Greater than 10 years of GMP manufacturing experience in the Pharmaceutical Industry
  • Minimum of 8 years of GMP Quality Assurance experience
  • Minimum of 5 years working with Contract Manufacturing Organizations
  • Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations
  • Demonstrated ability to work independently as well as in a team environment

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

Keywords: CRISPR Therapeutics AG, Cambridge , Associate Director, QA Operations, Other , Cambridge, Massachusetts

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