Join a pioneering small biotech company at the forefront of innovation in drug discovery and development. Committed to advancing novel therapeutics to improve patients' lives, we're seeking a Director of Quality Assurance to lead our quality efforts.
Position Overview
As the Director of Quality Assurance, you'll be instrumental in establishing and maintaining a robust quality management system to ensure industry best practices both internally and externally. Collaborating closely with cross-functional teams, you'll lead continuous improvement.
This opportunity will require the individual to be on-site 3 to 4 days a week in South San Francisco.
Key Responsibilities:
• Develop and implement a comprehensive quality assurance strategy aligned with company goals
• Lead the design, implementation, and maintenance of quality systems, policies, and procedures to support all aspects of drug development, manufacturing, and distribution.
• Provide strategic direction and oversight for quality assurance activities, including batch release, document control, deviations, investigations, and CAPA management.
• Lead and mentor a team of quality professionals, fostering a collaborative and high-performance culture.
• Conduct risk assessments and quality reviews to identify areas for improvement
• Serve as the primary point of contact for inspections, audits, and submissions as necessary.
• Stay updated on industry trends, regulatory updates, and emerging technologies, proactively recommending and implementing changes as needed.
Qualifications:
• Bachelor's degree in a scientific or related field; advanced degree preferred.
• Minimum of 10 years of progressive experience in quality assurance within the biotech or pharmaceutical industry, with at least 5 years in a leadership role.
• Extensive knowledge of cGMP, FDA regulations, and international quality standards applicable to biologics and small molecule drugs.
• Proven track record of developing and implementing quality systems and driving compliance in a fast-paced, dynamic environment.
• Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across all levels of the organization
