Quality Assurance Manager (Clinical)

InClin; San Mateo (CA); On-site; USD 109,000 - 136,000; Full time

Benefits offered by this job

401K

Paid Time Off

Health Insurance

Vision Insurance

Dental Insurance

Job summary

InClin, Inc. is seeking a highly skilled Quality Assurance Manager to join our team in a fully remote capacity. You will oversee QA activities, lead audits, manage the eQMS, CAPAs, and ensure GCP compliance from your home office.

Reporting to the Director of Quality, you will drive continuous improvement, review deviations, conduct risk assessments, and support regulatory inspections. Travel up to ~25% may be required for vendor or site audits.

Qualifications

• 8+ years in pharmaceutical or clinical quality settings.
• Strong knowledge of FDA regulations and ICH-GCP guidelines.
• Experience leading audits and CAPA processes.
• Familiarity with 21 CFR Part 11 preferred.
• Willingness to travel approximately 25% for audits.

Responsibilities

• Lead audits and maintain Annual Audit Plans for internal and CROs.
• Manage eQMS including document control and CAPA management.
• Oversee CSV and Change Control activities across systems.
• Review non-conformances, drive root cause analysis and corrective actions.
• Deliver GCP training to internal and contract personnel.

Skills

Quality Assurance

Audits

GCP

Document Control

CAPA

Training

Education

BS in science or related health discipline

Tools

eQMS

CSV

Change Control

FDA Regulations

Job description

Current job opportunities are posted here as they become available.

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.

What You Will Do (Key Responsibilities)

• SOP & Document Management: Write, revise, and review SOPs, policies, working practices, investigation reports, and quality metric trend reports.
• Audit & Inspection Leadership: 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.
• System Oversight: 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.
• Compliance & Guidance: 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.
• Training & Continuous Improvement: Develop quality indicators and metrics to monitor system effectiveness. Deliver GCP training sessions for internal and contract personnel.

What You Bring (Requirements & Skills)

• Education: B.S. or advanced degree in science, nursing, or a related health sciences discipline.
• Experience: 8+ years of experience within the pharmaceutical, biopharmaceutical, or clinical quality arena.
• Regulatory Expertise: Strong working knowledge of FDA regulations and ICH-GCP guidelines; familiarity with worldwide regulatory guidelines and 21 CFR Part 11 requirements is preferred.
• Travel: Ability to travel an average of 25% or less (primarily for required vendor or site audits).
• Certifications (A Plus): CQA (Certified Quality Auditor) or RQAP-GxP certification is a strong plus.

Why Choose InClin?

We offer a highly collaborative environment, competitive compensation, and the flexibility of a completely remote workspace with the infrastructure to support your success. InClin offers generous benefits including 401K, PTO, Health, Vision, and Dental insurance.

Compensation Range: $109,000 - $136,000 annually (dependent on experience)