Description
Freenome is seeking a Postmarket Quality Manager to oversee the postmarket quality infrastructure for its commercial launch. The successful candidate will build and run a complaint handling program that meets regulatory requirements across two distinct environments. They will also own the CAPA program, ensuring that complaints and quality events drive corrective action.
Responsibilities:
- Own the end-to-end complaint handling process, applying distinct regulatory requirements for CAP/CLIA laboratory quality events and IVD postmarket complaints under 21 CFR 820/QMSR and ISO 13485.
- Own the CAPA program, ensuring rigorous corrective action with documented root cause analysis, implementation, and effectiveness verification.
- Serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents.
- Interface with commercial partners and customer-facing teams to capture, evaluate, and act on partner- and customer-reported feedback and complaints.
- Monitor and analyze complaint, CAPA, and non-conformance trends; identify systemic issues and escalate with supporting analysis and recommended corrective actions.
- Compile and present quality signals data for management review and postmarket surveillance reporting.
- Participate in change control reviews and risk evaluations as the postmarket quality representative.
Requirements:
- Bachelor's degree in life sciences, clinical laboratory science, or a closely related field.
- 7+ years of quality assurance experience with direct ownership of a complaint handling or postmarket surveillance program in a regulated environment.
- Working knowledge of CAP/CLIA laboratory complaint and quality event requirements and how they differ from FDA postmarket complaint obligations under 21 CFR 820/QMSR.
- Hands-on CAPA program experience.
- Demonstrated ability to mentor or develop junior quality staff.
- Experience interfacing with external customers or commercial partners on complaint intake, communication, and resolution.
- Strong technical writing skills.
- Proficiency with an electronic QMS (eQMS) platform.
Nice to haves:
- Hands-on experience with CAP LAP inspections and NYSDOH Part 58 laboratory permit requirements.
- Experience in a molecular diagnostics, cfDNA, or NGS-based testing environment.
- Familiarity with MDR evaluation under 21 CFR Part 803.
- Prior experience building or formalizing complaint intake processes between a clinical laboratory and commercial partners or health system clients.
- ASQ CQA or equivalent quality certification.
Benefits:
- The US target range of base salary for new hires is $134,425 - $170,100.
- Eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits.