Quality Assurance Manager (Clinical)

Job Description

Job Description

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.

This is a full-time, exempt, remote position with corporate benefits, PTO, holidays, and 401k

To apply for this role, you should have...

• Proven experience in pharmaceutical, biotech, or CRO environments.
• Ability to manage multiple projects and interface with internal/external stakeholders.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• 8+ years of experience within the pharmaceutical, biopharmaceutical, or clinical quality arena
• Skills in audit planning, risk assessment, and quality system improvement.

A QA Manager in a CRO ensures compliance with Good Clinical Practice (GCP), regulatory requirements, and internal quality standards, overseeing audits, CAPAs, and vendor oversight to protect trial integrity and participant safety.

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: $100,000 - $136,000 annually (dependent on experience)

Ready to elevate your career in clinical quality? Apply today!