Jounce Therapeutics

Senior Specialist, Quality Assurance

Job ID
2021-1244
Category
Regulatory Affairs/Quality Assurance
Job Location
US-MA-Cambridge

Role / Responsibilities

Jounce Therapeutics is looking a for a Senior Specialist, Quality Assurance 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 GxP activities for clinical stage programs. This position will own Employee Training and spearhead document control and batch records across clinical programs.

 

Requirements:

  • 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.
  • Contribute to the generation, review and/or approval of internal and external documents used in GMP activities such as, but not limited to, master batch records, stability protocols/ reports, specifications, deviations, change controls etc.
  • Perform batch disposition and other relevant document management activities
  • Track and monitor QA performance metrics and data to drive continuous improvements of internal processes. Generate and evaluate data to support Key Performance Indicators.
  • Provide QA CMC Operations support for end to end supply chain coverage. This includes quality & compliance support of manufacturing, testing, packaging/ labeling and distribution activities by CMOs for Jounce’s drug substance and drug product global operations (i.e., Product Specifications, Batch Records, Deviations, Investigations, Change Control, QA Lot Disposition, Stability, Retest/Expiration Extensions, termperature excursions, Analytical Method Qualification/Validation).
  • Ensure that Jounce products meet defined quality standards through batch record review and facilitation of product-related investigations. 
  • Support external vendor audits, including oversight of vendor management program as needed.
  • Support eQMS implementation and converstion of current QMS to eQMS in a streamlined process to include training of systems
  • Other QA related job duties as needed with shifting of priorities
  • Minimum of Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, engineering or related field).

Qualifications

Qualifications:

  • 5+ years of pharmaceutical industry with Quality Assurance background in a GxP environment, clinical programs ranging from Phase 1-3
  • Experience with various QA documentation including batch records and training records
  • 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 (cGxP, ICH guidelines, EU Guidlines.) regarding sponsor responsitbilities 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 staff.
  • Proficient in Microsoft Office Operating System (applications to include: Word, Excel, Access, Visio, etc.) and other technology such as BOX, Sharepoint, Teams
  • Flexible schedule to maintain timelines and shifting priorities; ability to pay close attention to detail and and think strategically.

Statement

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

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 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 SELECT trial and with Jounce’s broader pipeline. Jounce’s next development stage product candidate, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state. A Phase 1 trial evaluating JTX-8064 is planned to begin enrollment in the fourth quarter of 2020. 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. For more information, please visit www.jouncetx.com.

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