Director, QMS

Job Title: Director of Quality Management Systems (QMS)

About: Our clientis a dynamic and innovative biotechnology company located in the San Francisco Bay Area. They are dedicated to advancing healthcare through groundbreaking research, development, and commercialization of novel therapeutics. With a commitment to quality, integrity, and patient-centricity, they strive to make a meaningful impact on global health.

Position Overview: We are seeking an experienced and strategic-minded Director of Quality Management Systems (QMS) to join their growing team. The Director of QMS will be responsible for developing, implementing, and maintaining a robust Quality Management System to ensure compliance with regulatory requirements, drive continuous improvement, and uphold the highest standards of quality across all aspects of our operations.

Key Responsibilities:

• Lead the development, implementation, and maintenance of the company's Quality Management System (QMS) in accordance with applicable regulatory requirements, including but not limited to FDA, ISO, and other relevant standards.
• Establish and oversee quality policies, procedures, and processes to ensure compliance, consistency, and efficiency throughout the organization.
• Provide leadership and guidance to cross-functional teams on quality-related matters, fostering a culture of quality and continuous improvement.
• Collaborate with internal stakeholders, including Quality Assurance, Regulatory Affairs, Research & Development, Manufacturing, and Clinical Operations, to ensure alignment and integration of quality objectives across the organization.
• Lead and support internal and external audits, inspections, and regulatory submissions, ensuring readiness and compliance with regulatory requirements.
• Drive corrective and preventive actions (CAPAs) and root cause analyses (RCAs) to address quality issues and drive sustainable improvements.
• Stay current with industry trends, regulations, and best practices related to quality management systems and quality assurance.
• Manage and develop a team of quality professionals, providing mentorship, training, and guidance to support their growth and development.

Qualifications:

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
• Minimum of 6 years of experience in quality assurance, quality management systems, or related field within the biotechnology or pharmaceutical industry.
• In-depth knowledge of regulatory requirements, standards, and guidelines applicable to biopharmaceutical quality systems (e.g., FDA regulations, ISO standards).
• Proven track record of successfully developing, implementing, and maintaining Quality Management Systems in a regulated environment.
• Strong leadership skills with the ability to influence and collaborate effectively across functions and levels of the organization.
• Excellent communication, presentation, and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Experience leading and managing a team of quality professionals.
• Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or similar certifications preferred.