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