Head of Quality & Compliance - ISO 17025/FDA Lead

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

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.