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Senior Vice President of Quality Assurance
2 months ago
We are seeking a highly experienced and skilled Senior Vice President of Quality Assurance to join our team at Annexon Biosciences. As a key member of our leadership team, you will be responsible for overseeing and implementing our quality management systems, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.
Key Responsibilities- Quality Management Systems: Develop, implement, and maintain robust quality management systems, including document control, deviation management, CAPA, and change control.
- Regulatory Compliance: Ensure compliance with FDA, EMA, and other regulatory agencies' regulations, directives, and ICH guidelines.
- Quality Risk Management: Identify and mitigate potential risks to product quality, patient safety, and regulatory compliance.
- Leadership and Collaboration: Lead cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments.
- Training and Development: Develop training curricula and provide leadership and oversight for training programs.
- Education: Undergraduate or graduate degree in pharmacy, chemistry, biology, or related scientific field; advanced degree preferred.
- Experience: Minimum of 18 years of experience, with at least 5 years in a senior leadership position.
- Skills: Excellent leadership, communication, and interpersonal skills; ability to influence and collaborate effectively across functions and levels of the organization.
- Diversity and Inclusion: We value diversity, equity, inclusion, and belonging, and strive to create a workplace where everyone can do their best work.
- Competitive Compensation: We offer a competitive base salary and equity participation, as well as a comprehensive health benefit package.
