Job Description

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.

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