Remote Clinical QA Manager - GCP & Compliance

InClin, Inc.; San Mateo, Northern (CA, KY); Hybrid; USD 109,000 - 136,000; Full time

Benefits offered by this job

401K

PTO

Health insurance

Vision

Dental insurance

Job summary

InClin, Inc. is a premier clinical research organization dedicated to data integrity and patient safety.

We are seeking a highly skilled Quality Assurance Manager to join our team in a fully remote capacity, enabling you to lead from your home office. Reporting directly to the Director of Quality, you will drive audits, manage the eQMS, oversee CAPA management, and ensure compliance with FDA/ICH-GCP guidelines.

Qualifications

• 8+ years of experience in pharmaceutical, biopharmaceutical, or clinical quality.
• Strong knowledge of FDA regulations and ICH-GCP; familiarity with 21 CFR Part 11 preferred.
• Ability to travel up to 25% for vendor or site audits.
• CQA or RQAP-GxP certification is a plus.

Responsibilities

• SOP and document management: write, revise, review SOPs and quality reports.
• Audit leadership: perform audits and manage annual audit plans; co-host FDA inspections.
• eQMS oversight: manage document control, training, deviations, complaints, and CAPAs.
• Compliance guidance: review non-conformances and ensure timely closure; QA rep on studies.
• Training and improvement: develop quality metrics and deliver GCP training.

Skills

Regulatory knowledge

Auditing

Quality systems

Training

Education

B.S. or advanced degree in science or health sciences

Job description

InClin, Inc. is a premier clinical research organization dedicated to data integrity and patient safety.

We are seeking a highly skilled Quality Assurance Manager to join our team in a fully remote capacity, enabling you to lead from your home office. Reporting directly to the Director of Quality, you will drive audits, manage the eQMS, oversee CAPA management, and ensure compliance with FDA/ICH-GCP guidelines.