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Head of Quality

Cellanome

Cellanome

Quality Assurance
Palo Alto, CA, USA
Posted on Thursday, May 11, 2023

We’re a well-funded early-stage start-up. You’ll get a chance to wear many hats, be a part of a growing team, and have the potential for exciting financial and career growth.

Here’s what sets us apart. We’ve set our sights on some of the biggest challenges facing biology today. We’re amassing a world class team of engineers, scientists, team builders and problem solvers to tackle these challenges heads-on. We’re passionate about developing the next generation technologies that will unravel the complexities of biology.

This is a unique opportunity to build, be part of an early-stage start-up and be surrounded by good humans who are super capable, humble and down-to- earth.

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.

What you can expect from us:

You’ll feel the energy when you walk in our door – we work hard, we have fun and we have ambitious plans to grow. Cellanome offers a comprehensive employment package that includes a competitive salary, generous stock options, great individual, and family health plans, a 401(k) and flexibility to balance work and life.

We embrace and celebrate the diversity of our employees. We are committed to equal employment opportunity regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law. We are proud to be an equal opportunity workplace.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.