A Leading immuno-oncology company based in Northern California is looking for a Head of Quality and Compliance and offering a competitive benefits package. This company is developing cell therapies for the treatment of cancer, genetic blood disorders, and autoimmune diseases and currently has four different molecules with various indications in trial stages, the furthest being in phase 3.
The Head of Quality and Compliance will oversee all the aspects of:
- Product Quality
- Quality Assurance
- GMP Facility Control
- Quality Services
- Quality Control Test Lab
- Quality Management System
Responsibilities will include but are not limited to:
- End-to-end product quality during the clinical and/or commercial phases in accordance with current Good Manufacturing Practices (cGMP) requirements.
- Ensuring that regulatory guidance is followed in accordance with current and future developments by aligning guiding documents and ensuring that the necessary activities are taken and recorded in the quality system in order to promptly fix any discovered gaps.
- Manage and adhere to production timelines
- Ensure alignment of GMP process documents/instructions to process descriptions
- Setting up quality checks for the GMP facility, managing certification of the GMP facility, validating alterations and upgrades to the GMP facility, environmental monitoring program, IQ/OQ/PQ of equipment, calibration, and maintenance of GMP equipment.
- Coordinating the efficient creation of a framework for company operations, compliance, quality risk management, quality assurance, internal and external audits, corrective and preventive action, and records
- Establishing and overseeing process for in-house testing of Company Products for 14-day Sterility, Gram Stain, and Endotoxin
- Examining and approving in-house quality test results and CoAs; assessing test reports produced by outside laboratories.
- Creating a framework for the Quality Management System that is in accordance with 21 CFR 211, 21 CFR 1271, and any applicable guidance for cell-based products issued by the FDA and other authorities.