Manager, Quality Systems

We are looking for an experienced Quality Assurance professional to join our team as Manager, Quality Systems supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in quality compliance, and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.

Responsibilities:

* Own and Manage TScans Vendor Management Program and ensure all GxP vendors are qualified as per approved procedures.

* Perform external (Vendor) audits and lead pre and post audit activities.

* Assist in TScans Internal Audit program. Perform internal audits as required and assist in pre and post audit activities.

* Assist in managing Deviation, CAPA, Change Control programs as needed.

* Assist in other Quality Management Systems including but not limited to Training Management and Doc Control programs.

* Author or revise applicable controlled documents related to quality systems.

* Generate, Issue and reconcile controlled documents for the GMP manufacturing environment

* Assists in the identification and implementation of continuous improvement opportunities.

* Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.

* Practice safe work habits and adhere to TScans safety procedures and guidelines.

* Perform other related duties as assigned to meet departmental and Company objectives.

Requirements:

* MS with 10-12 yrs /BS and 12-15+ years of experience, minimum of 8 in an FDA-regulated industry; high school diploma or GED required at minimum

* Experience with Veeva DMS, QMS or other electronic systems is plus.

* ASQ Quality Auditor and/or Manager of Quality Certification is plus.

* Must be able to read, write and speak English fluently.

* Experience in reviewing and creating controlled documents.

* Must possess strong documentation and communication skills.

* Excellent technical writing skills a plus

* Effectively demonstrates understanding of GxPs and Quality Systems and how they apply to specific responsibilities.

* Must be able to use a company-issued computer and have at least intermediate skills in Microsoft Word, Excel, Outlook, and PowerPoint programs needed to perform job.

About TScan:

TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScans discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors.

This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.

Do YOU have the anatomy of a TScanner?

Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.

EEO Statement

TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities.

To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied,…