Head of Quality

Sapho Bio•San Carlos, CA

1d•Onsite

About The Position

Sapho Bio is a revenue-generating biotechnology company developing a rapid microbiology release platform for the precision medicine era. The company is seeking a Head of Quality to own the quality system supporting laboratory results and to build the quality function as the company scales. The role is responsible for the company’s ISO/IEC 17025 accreditation and FDA registration, and serves as the primary point of contact for customer and regulatory audits. This is a full-time, in-person position in San Carlos, California. The posting emphasizes a demanding, fast-paced role that is not a 9-to-5 job and is not focused on work-life balance. Compensation is $200,000, along with equity options and benefits.

Requirements

BS or higher in chemical engineering, microbiology, chemistry, biology, or a related field.
At least 3 years of quality experience in a GMP-regulated laboratory, including 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 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.
Cover letter should give clear examples of exceptional work ethic, an accreditation, registration, or regulatory inspection led and its outcome, and a quality system built or substantially rebuilt and what was changed.

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.
Take on other work needed for the company to succeed.