Head of Quality

Sapho Bio; San Carlos (CA); On-site; USD 180,000 - 220,000; Full time

Benefits offered by this job

Unlimited PTO

Health coverage

401(k) with company match

Equity options

Job summary

Sapho Bio is seeking a Head of Quality to own the quality system that underpins every lab result. You will drive ISO/IEC 17025 accreditation and FDA registration, building the quality function as the company scales.

You will interact with customers and regulators during audits and inspections in an on-site role in San Carlos, CA. The ideal candidate is rigorous, smart, and hard-working, with a track record leading quality systems and regulatory activities in GMP labs.

Qualifications

• BS or higher in chemical engineering, microbiology, chemistry, biology, or related field.
• 3+ years of quality experience in a GMP-regulated laboratory with leadership.
• Hands-on experience leading ISO/IEC 17025 accreditation or hosting FDA inspections.
• Working knowledge of 21 CFR Part 211 and Part 11, and 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

Responsibilities

• Own and build out the quality management system, including document control, SOPs, training, and records management.
• Lead 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

Skills

Regulatory compliance

Quality leadership

Documentation

Written communication

Data integrity

Education

BS or higher in chemical engineering, microbiology, chemistry, biology, or related field

3+ years GMP quality experience in a regulated lab with leadership

Job description

Head of Quality

Department: Administration

Reports To: CEO

Location: On site, San Carlos, California

Employment Type: Full Time, Exempt, Salary

Compensation: $200,000 + equity options

About the Company

Sapho Bio is a revenue-generating biotechnology company developing a rapid microbiology release platform designed for the precision medicine era. We are a multidisciplinary team of scientists and engineers committed to transforming the lot release process through innovation, speed, and accuracy.

Our culture emphasizes agency, innovation, and continual learning. Following the successful validation and launch of our first proprietary assay, we now have over 30 customers and are growing quickly.

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 <71>, <1223>, and <85>
• 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

Life at Sapho Bio

• High-Impact Work: Help transform pharmaceutical testing and accelerate patient access to life-saving therapies.
• Comprehensive Health Coverage: Medical, dental, and vision insurance.
• Financial Security: 401(k) with company matching and company-paid life insurance.
• Time to Recharge: Unlimited PTO and company-recognized holidays.
• Connection & Community: Team lunches, office events, and offsite gatherings.
• Competitive Compensation: Market-leading salary and meaningful equity participation.
• Fast-Paced Environment: Join a team that moves quickly, learns continuously, and executes with purpose.
• World-Class Team: Work alongside experienced scientists, engineers, and operators.
• Prime Location: Sunny, collaborative workspace in San Carlos.