Associate Director, QA Operations

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

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

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