Head of Quality (Senior Director/Vice President)
- 200 Cambridgepark Dr, Cambridge, MA 02140, USA
Together with our elite cancer immuno-therapy scientists, you will be a part of our Drug Discovery teams leading projects to apply our ACTR (Antibody Coupled T cell Receptor) technology against different cancer indications. Our teams work from early discovery through launching programs into clinical development, offering you a great experience across the stages of invention. Our nimble and interdisciplinary approach to research can help you learn how to use creativity, cooperation, and critical thinking to solve hard problems. You’ll get to know scientists following diverse career paths and see for yourself how the extraordinary successes of immune therapies are creating new chances to help cancer patients.
- 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.