Manager, Quality Assurance

Job ID
2018-1124
Category
Regulatory Affairs/Quality Assurance
Job Location
US-MA-Cambridge

Company Summary

Jounce Therapeutics is an immuno-oncology company dedicated to transforming the treatment of cancer. The company is discovering and developing novel cancer immunotherapies designed to harness the immune system to attack tumors and provide long-lasting benefits to patients. Jounce integrates translational science insights including identification of related biomarkers designed to match the right immunotherapy to the right patients. The company is advancing programs that leverage contributions from its world-class founders as well as knowledge acquired from Jounce’s Translational Science Platform to create a sustainable “discovery to human proof-of-concept” product engine with the potential to drive significantly more durable responses to treatment. Founded by world leaders in tumor immunology, cancer biology and clinical and translational medicine, Jounce Therapeutics was launched in 2013 with funding from leading life sciences investor, Third Rock Ventures.

Role / Responsibilities

The Quality Assurance Manager/Senior Manager will be responsible for managing Jounce batch record review, CMO management, SOP creation and revision and performing external audits.  The incumbent will be expected to work with project teams as a quality representative to support Jounce clinical development programs.  In addition, the individual will work with project teams to ensure clinical studies and supporting activities are conducted in compliance with GxP.

 

Responsibilities:

 

  • Batch record review and disposition of Drug Substance, Drug Product and Finished Goods.
  • Provide SOP and GxP training at Jounce.
  • Maintain and continuously develop the QA procedures for phase appropriate compliance with FDA, EU and other applicable regulations.
  • Perform audits of GMP vendors (CMO’s, testing labs, packaging labeling vendors) against FDA regulations and ICH guidance documents.
  • Communicate compliance risks to senior management.
  • Domestic and international travel required.

Qualifications

Requirements:

 

  • Bachelor’s degree in a scientific discipline or health related field.
  • Minimum of 5-7 years of Quality Assurance industry experience.
  • Knowledge of current GMP, and GLP requirements, knowledge of European regulations a plus.
  • Strong written and verbal communication skills, interpersonal skills, technical writing skills, and the ability to work well in a team environment.
  • Computer system validation knowledge a plus.

 

Job title will be commensurate with education and experience of the selected candidate.

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