Head of Quality (Senior Director/Vice President)
- 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.
- Oversee both Quality Assurance and Quality Control functions across all GXP processes.
- Interact with regulatory agencies in regard to GXP matters
- Work to improve our current quality management systems and to establish Strategic Quality Objectives in support of development programs and Company goals
- Develop/maintain internal and external audit programs to satisfy contractual and regulatory requirements for GXP
- Identify, select, and implement scalable software to support Quality systems
- Coordinate the Quality review of documents for regulatory submissions
- Oversee pre-approval inspection readiness
- Develop and review qualification and validation plans and reports
- Optimize Quality Systems processes, including CAPA, Change Control, Document Control, Risk Management, identification of Critical Quality Events, etc.
- Establish adequate GMP, GCP and GLP training programs for the Company to support aggressive growth plan
- Manage and develop Quality Systems staff
- Promote Quality culture across functions
- Bachelor's Degree is required (Biological sciences, engineering or related degree); advanced degree a is a plus
- 15+ years of experience in Biotech/Pharma, with at least 5-10 years in a supervisory capacity
- Hands-on leader capable of performing lot release, data review, laboratory and facility audits
- Experienced in all phases of drug development; experience with cell therapy or novel modalities desirable
- Full range of QA experience in GMP and GCP; GLP knowledge beneficial
- Knowledge of current GXP qualification and validation expectations
- Experience with European quality guidance and Qualified Persons (QP) requirements
- Practical knowledge of implementation of I CH Q10 Quality Systems, especially Risk Analysis/Management, CAPA, Annual Product Reviews and Management Review and Supplier Quality Management
- Excellent leadership and management experience with the ability to lead a team
- Excellent team player and communicator
- Ability to demonstrate flexibility in the face of shifting priorities or unexpected occurrences in development
- Ability to interface well with all levels of personnel, including peers and other department heads such as: Manufacturing, Clinical, Regulatory and Project Management
All your information will be kept confidential according to EEO guidelines.