Associate Director of Quality Assurance

Regulatory & Quality Leadership Opportunity - Drive Innovation in Biopharma!Are you a seasoned Quality and Regulatory professional ready to take on a pivotal leadership role within a dynamic and growing biopharmaceutical organization? Our client, a cutting-edge company focused on advancing groundbreaking therapies, is seeking a highly skilled and experienced Director/Senior Director of Quality and Regulatory Affairs to join their team.What Youll Do:Strategic Quality Oversight: Spearhead supplier selection and audits, lead internal, client, and regulatory audits, and drive Quality Management and Review Board meetings.Risk Mitigation & Collaboration: Collaborate with cross-functional teams to identify and mitigate potential quality and regulatory risks, ensuring seamless operations.Regulatory Submissions & Compliance: Plan, prepare, and manage regulatory submissions (INDs, NDA/BLAs) in partnership with client stakeholders. Maintain regulatory registrations and licenses, ensuring compliance with FDA and international regulations.Inspection Readiness & Training: Develop and implement inspection readiness plans, conduct training sessions based on audit learnings, and prepare for regulatory inspections.Quality Management System Leadership: Implement and report on the performance of the Quality Management System, monitor progress against strategic quality goals, and provide strategic guidance to executive management.Regulatory Intelligence & Strategy: Stay abreast of regulatory intelligence, new guidance documents, and competitive information, and provide expert strategic guidance on regulatory requirements across all development stages.What You Bring:Bachelor's degree in a scientific discipline (advanced degree preferred).Minimum of 8 years of experience in compliance, quality, and CMO management within the pharmaceutical or biotechnology industry, with a focus on regulatory documentation and lifecycle management.5+ years of experience in management/leadership roles within QA.8+ years of experience in a QA management role.Minimum of 10 years of GMP experience.10-12 years of overall QA related experience.Deep knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs.Extensive experience with FDA and EU regulatory inspections.Expertise in drug substances and drug products.Strong understanding of aseptic manufacturing processes.Broad knowledge of FDA and international regulations related to GMPs and Biopharma.Proven ability to independently manage work responsibilities with minimal oversight.Exceptional time and project management skills, with the ability to multitask and meet deadlines.Excellent verbal and written communication, interpersonal, and customer service skills.Strong analytical, problem-solving, and organizational skills.Ability to prioritize tasks and delegate effectively.Expert working knowledge of the full drug development process and FDA/ICH regulatory requirements.Strong strategic, analytical, and negotiation skills.Ability to influence and motivate others.Self-motivated, detail-oriented, and innovative.

Created: 2025-03-08