Quality Assurance Manager (Clinical)

InClin•San Mateo, CA

5d•Remote

About The Position

InClin, Inc. is a premier clinical research organization dedicated to delivering exceptional service and ensuring the highest standards of data integrity and patient safety. We are seeking a highly skilled and motivated Quality Assurance Manager to join our team in a fully remote capacity. Reporting directly to the Director of Quality, you will manage compliance with company policies, procedures, GCP regulations, and all applicable guidelines. You will lead audits, manage our eQMS, oversee CAPA management, and champion a culture of continuous improvement across the organization—all from the comfort of your home office.

Requirements

B.S. or advanced degree in science, nursing, or a related health sciences discipline.
8+ years of experience within the pharmaceutical, biopharmaceutical, or clinical quality arena.
Strong working knowledge of FDA regulations and ICH-GCP guidelines.
Ability to travel an average of 25% or less (primarily for required vendor or site audits).

Nice To Haves

Familiarity with worldwide regulatory guidelines and 21 CFR Part 11 requirements is preferred.
CQA (Certified Quality Auditor) or RQAP-GxP certification is a strong plus.

Responsibilities

Write, revise, and review SOPs, policies, working practices, investigation reports, and quality metric trend reports.
Perform audits and maintain Annual Audit Plans for internal departments, CROs, specialty service providers (EDC, e-diaries, IVRS), and clinical studies.
Co-host FDA and regulatory inspections.
Manage the company-wide electronic Quality Management System (eQMS) for Document Control, Training, Deviations, Complaints, and CAPAs.
Oversee Computer System Validation (CSV) and Change Control Management.
Review non-conformance situations, evaluate root causes and corrective actions, and ensure timely closure.
Act as the designated QA Representative on clinical studies for Protocol Deviation Reviews and Risk Management.
Develop quality indicators and metrics to monitor system effectiveness.
Deliver GCP training sessions for internal and contract personnel.