GXP Quality Assurance Director

The (Senior) Director of Quality Assurance (QA) will provide strategic and technical leadership for the optimization and administration of a complete Quality Program at Arcus, which currently has 4 molecules in clinical trials. This individual will have oversight of all GCP, GMP, and GLP (GXP) QA functions, in compliance with FDA, European and other country-specific regulations. This individual will be responsible for developing collaborative and productive partnerships internally as well as externally with contract research/manufacturing organizations. Arcus is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making. This newly created position reports directly to the company’s CEO.

Primary responsibilities

• Develop GXP Quality Systems, as needed, to ensure that Arcus is compliant with relevant regulations, in a development phase-appropriate manner, from preclinical to clinical development and commercialization of our products
• Support investigational new drug applications (IND/IMPD), ex-US clinical trial applications (CTA), and related correspondence from FDA and other global regulatory authorities    
• Responsibility for QA Operations and QA Compliance functions
• Manage Document Control functions
• Participate in cross-functional teams, providing feedback and support
• Partner with external vendors in support of Quality document preparation and submission
• Oversee and manage GXP QA monitoring activities, including all internal and external audits of GXP service providers
• Manage investigations, due-diligence assessments, regulatory agency inspection preparation activities, and other QA activities
• Verify that appropriate corrective actions are taken as a result of audit observations and investigations, when necessary, and ensure timely closure of GXP audit activities
• Maintain up-to-date knowledge of the GXP quality landscape, regulations, and guidelines
• Responsibility for identifying GXP risks and mitigation plans
• Identify and oversee consultants that perform specific GXP QA work for the company

Qualifications and Experience

• Bachelor’s degree required. Advanced scientific degree strongly preferred.
• Minimum of 12-15 years of relevant GXP experience in a biotech/pharmaceutical setting; the ideal candidate will have some exposure to GLP/GMP Quality, with at least 10 years of relevant GCP experience
• Broad understanding of international regulations and guidance documents
• Strong experience in IND and CTA filings; NDA/BLA/MAA experience strongly preferred
• Experience in CMO and CRO auditing; ability to travel occasionally
• Experienced manager of other full-time employees as well as contractors
• Well-prepared, competent, and confident when interacting with senior management, regulatory authorities, and internal and external partners
• Ability to remain objective/autonomous in overseeing the Quality Program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
• Track record of successful participation in multi-functional projects
• Excellent interpersonal, verbal, and written communication skills