Director GMP Quality

About us:

Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs.

We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written.

Job Summary:

This position is hands on role within Arcus Biotechnology's QA organization. The responsibility of the incumbent includes but not limited to quality oversight of GMP Quality Management System, Standard procedures, and Governance Quality Process across organizations. Leading risk management initiatives including risk assessment within quality processes, tracking and trending of Quality Metrics, hand's on support of Supply Chain Quality Operations and QP interactions. The incumbent will also manage CMC documents archived in the company's electronic data management system. Provide training for functional teams, support, and escalate compliance issues to senior management in a timely manner. This is a highly visible role with responsibility and cross-functional influence across departments. It's a role that requires tactical decision-making skills.

Job Responsibilities:

• Oversight of all processes related to management of Arcus GMP Quality System and infrastructure (Deviations, CAPA's Change Control, Complaints, Risk Management, etc.).
• Lifecycle oversight of Arcus' processes and procedures. Assess current procedures and create new procedures as needed to ensure compliance with industry standards and health authority requirements. Identify opportunities to streamline systems and processes.
• Manage the maintenance of documentation archived within Arcus' electronic data management system. Responsible for managing and ensuring the archival of all CMC related data.
• Provide Quality guidance cross functionally to ensure compliance with KPI targets. Monitor performance metrics and drive continuous improvements of internal processes.
• Manage and facilitate ongoing Quality Management Review.
• Lead and execute projects related to PQS to support data-driven QA development processes
• Support regulatory filings and inspection as needed
• Representation of QA across the organization by providing GMP guidance during training.
• Responsible for supply chain quality oversight. Support CMO packaging, labeling, and logistics operations.
• Manage batch traceability (genealogy) of packaged clinical materials.
• Manage product complains and temperature excursions.
• Responsible for QP interactions
• Other duties as assigned

Qualifications (including knowledge & skills):

Bachelor of Science degree, in a related scientific discipline

Core Competencies, Knowledge and Skill Requirements

• In-depth knowledge of GMPs (EU, US, AU, JP)
• Experience in working with external partners and/or contract manufacturing
• In-depth knowledge of Quality principles, concepts, industry practices and standards
• Excellent verbal, written and interpersonal communication skills
• Ability to work independently with scientific/technical personnel
• Knowledge of risk management tools

Communication & Interpersonal Skills

• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail

Significant Contacts

• Interacts with all levels of Arcus Bio employees including CMOs