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Associate Director of Quality Assurance
1 month ago
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 You'll 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.
