Associate Director of Quality Assurance

Company: GeneFab
Location: San Francisco
Posted on: April 6, 2025

Job Description:

The Associate Director of Quality Assurance is a pivotal leader in cultivating a culture of quality, operational efficiency, and excellence. This role ensures that quality and compliance are seamlessly integrated into daily operations and aligned with the organization's long-term Quality strategy. The position provides strategic direction and oversight for Quality Assurance functions, driving end-to-end harmonization of quality processes, including risk management, GMP core management, and adherence to global regulatory requirements. Success in this role depends on fostering and leveraging strong partnerships with key stakeholders to execute strategies that align with and support the organization's business priorities.$160,000 - $190,000 a yearResponsibilities:

• Providing support and oversight for supplier(s) selection and leads supplier audits.
• Leads internal audits, client audits and regulatory inspections.
• Provides support and oversight of Quality Management Review meetings.
• Provides support and oversight of "QRB" Quality Review Board meetings.
• Providing support and oversight for meetings focused on reviewing and assessing open gaps, while collaborating with cross-functional teams to mitigate potential risks.
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Determine the strategy for and lead the implementation and execution of inspection readiness plans and activities.
• Develop and provide training sessions based on previous and current audit and inspection learnings.
• Plan, prepare, and manage submissions (INDs, NDA/BLA regulatory filings in strong collaboration with Genefab's clients).
• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, program teams and senior management, as relevant.
• Prepare and manage Genefab's regulatory registrations and/or licenses (e.g., FDA).
• Remain current on Regulatory Intelligence, new guidance documents and competitive information to provide comprehensive information to program teams.
• Independently provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for projects.
• Responsible for the implementation and reporting of the performance of the Quality Management System to the executive management team.
• Establishes or administers an organizational quality management system and monitors progress against strategic quality-related goals.
• Performs other duties as assigned.Qualifications:
• Minimum of a bachelor's degree, preferably in a scientific discipline.
• A minimum of 8 years of experience in compliance, quality, and CMO management with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry is a must, including 5 years of experience in management/leadership roles.
• 8+ years in a QA management role.
• Minimum of 10 years of GMP experience.
• 10-12 years of QA related experience required.
• General knowledge of aseptic manufacturing processes.
• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
• Experience organizing and managing work responsibilities while working independently with minimal oversight.
• Time and project management skills with the ability to multi-task and meet deadlines.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Deep knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs.
• Experience with regulatory inspections by the FDA and EU authorities.
• Experience with drug substances and drug products is desired.
• Knowledge of regulatory requirements across development stages and post-approval is essential.
• Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.
• Strong strategic and analytical abilities, diplomacy, and negotiation skills.
• The ability to collaboratively influence across multiple functions and motivate others to accomplish company objectives.
• Ability to work flexibly within tight timelines and with strong project management skills.
• Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities.
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Keywords: GeneFab, San Francisco , Associate Director of Quality Assurance, Executive , San Francisco, California