GXP Quality Assurance Director

Hayward, California
Oct 19, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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