Job Title: Manager / Director of Quality Assurance
Position Summary
Our client seeks an experienced and dynamic Manager / Director of Quality Assurance (QA) to join their team in the East Bay region of the San Francisco Bay Area. Reporting directly to the Chief Scientific Officer (CSO), this role is pivotal in establishing and maintaining robust quality systems for nonclinical laboratory studies compliant with Good Laboratory Practice (GLP) and clinical study testing activities aligned with Good Clinical Laboratory Practice (GCLP). The Director of QA will ensure facilities, equipment, personnel, and processes adhere to regulatory standards, supporting our organization's commitment to excellence and compliance.
Key Responsibilities
Inspection Readiness & Audits:
Host client and regulatory inspections, including preparing comprehensive responses to findings.
Plan, conduct, and report internal facility inspections and external vendor audits to assess compliance with regulations and industry best practices.
Regulatory Compliance & Support:
Establish compliance with GLP, GCLP, and GCP standards for FDA and applicable international regulations.
Monitor and interpret regulatory landscapes, applying requirements to optimize business processes and procedures.
Provide regulatory support across the organization's sites and functions.
Documentation & Reporting:
Establish and maintain QA SOPs, QA Files, QA Audit Logs, and a Master Schedule.
Prepare monthly compliance status reports for Test Site Management (TSM), including problem areas and corrective actions.
Review and author critical documentation, including Standard Operating Procedures (SOPs) and Statistical Analysis Plans (SAPs).
Team Leadership & Development:
Recruit, mentor, and develop a team of regulatory professionals.
Foster a growth-minded, supportive culture that encourages professional development.
Training & Communication:
Provide training on GLP and GCLP requirements to internal teams.
Represent QA in cross-functional meetings and initiatives.
Qualifications & Educational Requirements
Education:
BA/BS in Biological or Physical Sciences required; Advanced degrees (MA, PhD) preferred.
Experience:
Minimum of 10 years of relevant regulatory affairs experience in the bioanalytical CRO, biotechnology, or pharmaceutical industries.
Proven expertise in GLP/GCLP compliance, regulatory audits, and risk management.
Skills:
Exceptional leadership and team management capabilities.
Strategic thinker with a proven ability to propose innovative solutions to complex regulatory challenges.
Strong interpersonal, communication, and organizational skills.
Why Join Us?
This is an opportunity to play a leadership role in a company that values quality, innovation, and collaboration. You'll work in a fast-paced, science-driven environment, shaping regulatory practices that impact critical research and development efforts globally.