Senior Quality Assurance Specialist

Location: San Francisco Consulting
Department: Azzur San Francisco LLC

Job Description

Responsibilities

  • Draft, revise, and / or approve controlled documents needed to support partner / contractor relationships and QA management activities.
  • Responsible for design and implementation of quality and compliance systems for in-house and contract manufacturing for early-stage gene modified cell therapy clinical trials.
  • Direct development, initiation and maintenance of all quality systems in support of the product(s).
  • Represent QA on project teams and with contract manufacturers as required. Direct all aspects of quality support and strategy for the project team on the designated product(s).
  • Review and approve partner/contractor GLP / GCP / GTP / GMP documentation on behalf of QA and Operations.
  • Review batch documentation and make recommendations for dispositioning product lots. Oversee unexpected event investigations (OOS, deviations, non-conformance), change control, CAPA, label review/approval for manufacturing and testing operations.
  • Actively monitor ongoing contractor-related research, manufacturing, quality control testing, and other activities. Provide feedback to stakeholders in a timely manner as per established Quality Agreements.
  • Ensure the project team objectives and timelines are supported by quality deliverables; including but not limited to strategic planning, resource capabilities/allocation, budgeting, and tracking of risks and issues.
  • Responsible for audit preparation, training, and serve as lead FDA liaison during audits.
  • Drive implementation of document control systems and promote adherence to company regulations, policies, SOPs, and guidelines. Identify and anticipate trends in quality issues, collaborate with leadership team to implement quality initiatives.
  • Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.
  • Manage, train, recruit, and direct all staff in stage appropriate GMP.

Qualifications

  • Bachelor's degree in life science or related discipline.
  • At least 10 years of Quality Assurance experience in FDA regulated industry, preferably, biologic therapeutics.
  • Prior experience with IND and early clinical stage cell/gene therapy programs.
  • Competence in FDA and international GMP requirements.
  • Excellent verbal and written communication skills; ability to lead Quality function as part of multi-faceted projects.
  • Strong interpersonal skills; able to deal effectively with a variety of internal and external personnel. Experience with change management.
  • Proficient in MS Office applications


Apply Now