Associate Director – Quality Assurance

MSD

. Prepare and conduct QA audits, including prolonged auditing in China .

Posted 10/5/2026full-timeRemote • United StatesSenior💰 $129,000 - $203,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in conducting GCP audits and quality assurance processes, with a strong focus on risk-based auditing and regulatory compliance in the Asia Pacific region. Proven ability to communicate effectively with stakeholders and manage quality issues through thorough analysis and corrective actions.

Highest-signal resume keywords

GCP AuditingQuality AssuranceRisk-Based AuditsAudit ManagementRegulatory Compliance

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

GCP AuditsQuality SystemsAudit ReportingRisk AssessmentCorrective ActionsPreventative ActionsRoot-Cause AssessmentQuality Risk ManagementProject ManagementData Analysis

Soft Skills

CommunicationCollaborationProblem-SolvingStakeholder EngagementCultural Sensitivity

Industry Keywords

Quality AssuranceRegulatory ComplianceAsia PacificInvestigator SitesThird-Party CollaborationsDue DiligenceQuality EventsSignificant Quality IssuesAudit SubstrateGCP Regulations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Prepare and conduct QA audits, including prolonged auditing in China
Generate audit reports and communicate results to QA management and relevant external stakeholders
Interact with teams to ensure corrective and preventative actions close QA observations
Collaborate with colleagues in China on cultural considerations, global-study responsibilities, and local GCP and new drug application regulations
Identify potential risks and prepare and perform risk-based audits using critical-to-quality factors
Conduct GCP audits of investigator sites, country offices, suppliers, third-party collaborations, and due diligence activities
Support identification and scheduling of audit substrate in China in alignment with risk assessments and Japan/China Lead input
Facilitate communication and alignment with stakeholders regarding quality events and audit findings
Participate in Significant Quality Issues management, including root-cause assessment and remediation
Escalate quality issues, potential misconduct, and significant deviations to the QAL and TA Head

Requirements

What you’ll need

Bachelor's degree (BS/BA) or equivalent preferred
Minimum of 5 years of experience in a relevant field
Experience conducting GCP routine and directed audits
Experience auditing investigator sites, country offices, suppliers, third-party collaborations, and due diligence activities
Ability to analyze critical-to-quality factors and perform risk-based audits
Ability to travel to/within China, including extended stays of 2–3 weeks per quarter
Travel requirement of 75% in Asia Pacific (China), including ROW as needed
Quality assurance, quality auditing, quality systems, and regulatory compliance knowledge
Audit management and quality risk management skills
Project risk assessment and action plan development skills
No visa sponsorship
Must be a US or Puerto Rico resident
No valid driving license required

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical healthcare benefits for employee and family
Dental healthcare benefits for employee and family
Vision healthcare benefits for employee and family
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Remote work arrangement