About The Role
We are looking for a Head of Quality to own the quality system behind every result our lab releases. Our customers make lot release decisions based on our data, so the quality of that data is the product.
You will be responsible for our ISO/IEC 17025 accreditation and FDA registration, and you will build the quality function as the company scales. This role sets the standard for how the lab operates, and you will be the person customers and regulators deal with when they audit us.
You are a good fit for this role if you are
rigorous,
smart, and above all
hard-working.
Application Requirements:
- Your cover letter should give clear examples of the following:
- An instance in which you demonstrated an exceptional work ethic
- An accreditation, registration, or regulatory inspection you led, and the outcome
- A quality system you built or substantially rebuilt, and what you changed
- This job is not 9-5
- This is an opportunity to work very hard, learn a lot, and develop skills that will serve you well throughout your career
- This is not an opportunity to focus on work life balance
Who You Are:
- BS or higher in chemical engineering, microbiology, chemistry, biology, or a related field
- 3+ years of quality experience in a GMP-regulated laboratory, with at least 1 year in a leadership role
- Hands-on experience leading ISO/IEC 17025 accreditation or hosting FDA inspections
- Working knowledge of 21 CFR Part 211 and Part 11, and of data integrity expectations
- Experience running deviation, CAPA, OOS, and change control processes
- Excellent written communication and documentation skills
- Live within a 30 minute commute of San Carlos
Nice to Haves:
- Quality experience at a contract testing laboratory
- Background in QC microbiology, sterility testing, or rapid microbiological methods
- Familiarity with USP , , and
- Experience with A2LA accreditation
- Experience implementing an electronic QMS or LIMS
- Prior experience at a startup
Responsibilities:
- Own and build out the quality management system, including document control, SOPs, training, and records management
- Lead the company through ISO/IEC 17025 accreditation and FDA registration, and maintain them afterward
- Run deviation, CAPA, OOS investigation, and change control processes
- Oversee method validation and verification, and approve validation protocols and reports
- Host customer audits and regulatory inspections, and manage responses to findings
- Negotiate and maintain quality agreements with customers
- Qualify and monitor suppliers and critical materials
- Ensure data integrity across the lab, including electronic records and systems
- Report quality metrics to leadership, and hire and manage the quality team as it grows
- Whatever else is needed for the company to succeed
Details:
- This is a full-time in-person role in San Carlos, CA
- The compensation for this role is $200,000 along with equity options in the company and benefits
