Quality Assurance Manager (Clinical)

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 organizationall 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 -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: $109000 - $136000 annually (dependent on experience)

Ready to elevate your career in clinical quality Apply today!