Director, QMS

Job Title: Director of Quality Management Systems (QMS)

About:

Our client

is 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.