Manager, Quality Systems

TScan Therapeutics•Waltham, MA

13h•Onsite

About The Position

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.

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 in reviewing and creating controlled documents.
Must possess strong documentation and communication skills.
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.

Nice To Haves

Experience with Veeva DMS, QMS or other electronic systems is plus.
ASQ Quality Auditor and/or Manager of Quality Certification is plus.
Excellent technical writing skills a plus.

Responsibilities

Own and Manage TScan’s 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 TScan’s 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 TScan’s safety procedures and guidelines.
Perform other related duties as assigned to meet departmental and Company objectives.