GXP Quality Assurance Director

Hayward, California
Jul 27, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

GXP Quality Assurance Director

The Quality Assurance (QA) Director will provide strategic and technical leadership for the development and administration of a complete Quality Program for the manufacture, testing, and release of clinical materials as well as oversight of all GMP, GLP, GCP (GXP) QA functions, in compliance with FDA and European regulations. This individual will be responsible for developing collaborative and productive partnerships internally as well as externally with contract research/manufacturing organizations. This individual will also be responsible for the technical execution of all GMP and GCP QA activities. 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 President of the company.

Primary responsibilities

  • Develop GMP and GCP 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
  • Independently execute technical deliverables, including Quality Agreements, batch record review and lot release
  • 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
  • Manage investigation, due dilligence 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.
  • Oversee and manage GCP QA monitoring activities
  • Maintain up-to-date knowledge of the GMP and GCP quality landscape, regulations, and guidelines
  • Responsibility for identifying GXP risks and mitigation plans
  • Manage internal and external audits of GXP service providers

Qualifications and Experience

  • Bachelor’s degree required.  Advanced scientific degree strongly preferred.
  • Minimum of 15 years of relevant experience in small molecule and/or biologics (monoclonal antibodies specifically) GMP QA 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
  • Flexible attitude with respect to work assignments and new learnings
  • Excellent interpersonal, verbal, and written communication skills
  • Well-prepared, competent, and confident when interacting with senior management, regulatory authorities, and internal and external partners
  • Ability to manage multiple and varied tasks in a fast-moving environment
  • Good record-keeping skills