Quality Assurance Manager

Jounce Therapeutics
 Cambridge, MA

Role / Responsibilities

The Quality Assurance Team Jounce is hiring! We are seeking a Senior Specialist/QA Manager, QA to join a highly experienced team dedicated to transforming the treatment of cancer. The ideal candidate will have a strong understanding of regulatory requirements and industry standards to support daily cGxP activities for clinical stage programs. This position will develop and maintain the Quality Management System (QMS) and provide Quality Oversight. The QA Manager will initiate and implement quality improvement activities as appropriate to raise performance of the company systems and services; additionally, they will guide and mentor designated representatives as well as trains company employees regarding their impact on the process streamlining, improvements, and QMS.

Responsibilities

  • Lead QA Document Control and GxP Employee Training records through collaboration with key stakeholders in identifying phase-appropriate SOPs, and continued development of GxP employee training program;
  • Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation;
  • Support the implementation of Jounce eQMS to include EDMS/Training to include training of systems in phase appropriate manner;
  • Author, review or revise QMS relevant controlled documents;
  • Coordinate and facilitate QMS internal and external audits as applicable;
  • Manage the Quality Management System (QMS) including Deviations, Corrective Actions/Preventive Actions process (CAPA) and Change Controls;
  • Develop, implement, maintain and improve business unit wide quality assurance systems, including tools, policies, training and processes;
  • Lead problem solving team and participate in continuous improvement initiatives;
  • Manage quality data for accuracy and report generation; and
  • Manage other QA related job duties as needed with shifting of priorities including batch disposition activities and CMO quality oversight support.

Qualifications

  • 5+ years of pharmaceutical industry with Quality Assurance background in a GxP environment supporting clinical programs ranging from Phase 1-3 required;
  • Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, engineering or related field);
  • Possess a strong quality & compliance background and the ability to communicate effectively in a cross-functional team environment;
  • Ability to apply quality system concepts to daily operations. Understanding of applicable regulations (21CFR Part 210, 211,312, ICH guidelines (E6, Q7, Q9, Q10,) regarding sponsor responsibilities in building a phase based QMS;
  • Ability to work both independently with direction and within functional teams, to attain group goals;
  • Demonstrate strong organizational skills, including the ability to prioritize workload;
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including scientific and manufacturing/clinical staff;
  • Proficient with the use of electronic GxP systems and applications such as Veeva, Box, SharePoint, Microsoft Office Operating System (Word, Excel, PowerPoint); and
  • Flexible schedule to maintain timelines and shifting priorities.

Statement

Diversity and Inclusion Statement

Jounce strives to create a workplace that reflects the diversity of cancer patients, and where all feel included and valued because of their differences. Actively including people who add to our culture and enhance our values leads to better decisions and outcomes for those we serve – patients, all patients. Beyond our walls, our focus is on addressing inequities in opportunities for STEM education, careers opportunities in Biotech, and access to cancer care.

Equal Opportunity Employer

Jounce Therapeutics is an equal opportunity employer and does not discriminate in its employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs. We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S.

Company Summary

Company Overview

Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce’s highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. A Phase 1 clinical trial, named INNATE, for JTX-8064 as a monotherapy and in combination with JTX-4014, Jounce’s internal PD-1 inhibitor, or pembrolizumab is currently enrolling patients with advanced solid tumors. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce’s broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc.

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