Quality Systems Manager
- 200 Cambridgepark Dr, Cambridge, MA 02140, USA
Unum Therapeutics is a clinical-stage biopharmaceutical company focused on developing curative cell therapies to treat a broad range of cancer patients. Unum’s novel proprietary technologies include Antibody-Coupled T cell Receptor (ACTR), an autologous engineered T-cell therapy that combines the cell-killing ability of T cells and the tumor-targeting ability of co-administered antibodies to exert potent antitumor immune responses, and Bolt-On Chimeric Receptor (BOXR), designed to improve the functionality of engineered T cells by incorporating a “bolt-on” transgene to overcome resistance of the solid tumor microenvironment to T cell attack. Unum has multiple programs in Phase 1 clinical testing and preclinical testing, including; ACTR707 used in combination with trastuzumab in adult patients with HER2+ advanced cancer and used in combination with rituximab in adult patients with r/r NHL; and BOXR1030 expressing the GOT2 transgene and targeting GPC3+ solid tumor cancers.
Unum’s BOXR1030, the first preclinical product candidate to emerge from the BOXR platform, is composed of a GPC3 targeted CAR and a “bolt-on” enzyme called glutamic-oxaloacetic transaminase 2 (GOT2) that aims to improve T cell function in the solid tumor microenvironment through enhanced metabolism. GOT2 plays a central metabolic role by linking multiple pathways involved in biosynthesis and cellular energy production.
Unum Therapeutics is headquartered in Cambridge, MA.
You will report to the Head of Quality and be a valuable leader and contributor to other initiatives as they arise in our fast paced, start-up environment. In this role you will help to build and maintain Unum’s quality systems, with responsibilities including:
- Manage Core Quality System elements (Document Control and management, Change Control, Deviations, CAPA, Training, and Vendor Management)
- Oversee and assist in the creation of SOPs, specifications, work instructions, and other quality documentation across the organization
- Administer the electronic document management system (EDMS) use and operation throughout the company
- Work with functional area managers to assure appropriate and timely training of GxP personnel
- Track and trend internal Quality metrics and report to senior management
- Work with other Quality staff and cross-functionally to assure timely execution of investigations, corrective action implementation, and closure of GxP quality events
- Oversee the vendor management program, including tracking of qualified vendor status, scheduling of 3rd party audits and responses
- As needed, perform batch release and work closely with other QA and Operations personnel to assist in Unum’s GMP operations.
- An independent, flexible, high-energy Quality professional with a demonstrated record of achievements in quality assurance systems in biologics or a related field.
- Well versed in FDA/ICH/EU regulations and guidelines
- A demonstrated ability to lead a functional area and drive cross-functional results.
- 5+ years of experience in quality management.
- Experience with cell or gene therapy is a plus.
All your information will be kept confidential according to EEO guidelines.