Quality Auditor

For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors.

We're seeking an experienced
Pharmaceutical Quality Auditor
based in
China
to perform
supplier audits
for pharmaceutical commodities, including
packaging materials, excipients, raw materials, APIs
, and more.

This is a
contract opportunity
offering flexibility — you can accept or decline assignments based on your availability.

You must have demonstrated experience as a
Lead Auditor
with direct knowledge of
21 CFR 210/211, EudraLex Vol. 4, China GMP, and ICH Q7
requirements.

Key Responsibilities

• Conduct 1–2 day on-site audits across China at supplier facilities (e.g., Zhejiang, Ningbo, Sichuan, Shandong, and others)
• Evaluate compliance with pharmaceutical GMP standards, regulatory requirements, and client-specific expectations
• Prepare, execute, and complete supplier audits, including audit plans, checklists, and detailed reports
• Identify nonconformances and assess supplier CAPA responses as required
• Ensure audit reports are completed and submitted per SQA client specifications and deadlines
• Communicate effectively with the SQA Content Team to address feedback and report revisions
• Represent SQA professionally with both suppliers and clients

Required Qualifications

• Minimum 5 years of auditing experience within the pharmaceutical industry
• Lead Auditor experience, having conducted 10 or more on-site audits independently
• In-depth knowledge of 21 CFR 210/211, EudraLex Vol. 4, China GMP, and/or ICH Q7
• Fluent in Chinese (Mandarin) and English (written and spoken)
• Strong audit documentation and reporting skills
• Excellent organizational and interpersonal communication skills
• Availability for at least two audits per month (contract-based, project work)
• Ability to travel within mainland China

Preferred Qualifications

• Experience auditing additional standards such as ISO 9001, ISO 15378, EU GDP, ISO 17025, or 21 CFR Part 58/820
• Prior experience auditing pharmaceutical raw material, API, or packaging suppliers
• Certification as a Lead Auditor in GMP or ISO is a strong plus

Note:
SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.

This position requires access to ITAR-controlled technical data and/or defense articles. As such, the candidate must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with the International Traffic in Arms Regulations (ITAR). Applicants who do not meet these criteria will not be considered for this role.

$1,600 – $1,700 USD per day
(inclusive of preparation, travel time, audit execution, reporting, and revisions).

Travel expenses
reimbursed at cost with receipts per SQA policy.

Flexible engagement — you choose which audits to accept based on your availability.