Cellanome is seeking a highly skilled, self-driven, and experienced individual to join as our Head of Quality. Reporting to the Head of Operations, this is a highly visible, collaborative, and impactful role.

• Build our Quality function from scratch – an opportunity to put your fingerprints on a critical function that will have lasting impact on our future customers and our organization
• Lead the development of our QMS
• Develop and maintain effective relationships with internal stakeholders, external suppliers, and regulatory bodies.
• Build a culture of quality, bringing a pragmatic approach that focuses the organization on our highest priorities.
• Build and provide leadership and guidance to the quality control and quality assurance teams.
• Ensure timely and accurate completion of all quality control and quality assurance activities, including documentation and record keeping.
• Ensure that all deviations, investigations, and corrective actions are properly documented and resolved in a timely manner.
• Develop and implement training programs to ensure that all employees are trained in quality management principles and procedures.
• Monitor and analyze quality metrics to identify areas for improvement and implement corrective actions as needed.
• Stay current with all relevant regulations and standards and ensure Cellanome is compliant.
• Drive and oversee broad set of activities such as:
  • Documentation and document control
  • Supplier quality management
  • DHF and records
  • Audit management
  • Certifications

Role Requirements:

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
• Minimum 10 years of experience in quality control and quality assurance in the biotech, medical device, or the life sciences tools space.
• Prior leadership experience in a startup environment.
• Working knowledge of relevant regulations and standards (e.g., FDA, ISO9001, 13485, GMP).
• Proven track record of successfully implementing, maintaining, and demonstrating value of a comprehensive quality management system.
• Flexibility to adapt to a rapidly changing work environment and manage competing demands.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to collaborate, build relationships, and influence teams to work towards common goals.

We provide competitive total compensation packages, including base pay, benefits, and equity. In California the base salary range for this position is $200,000 - $230,000/year. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.