Associate Director, Quality Assurance

Our Research & Development Division QA Clinical Quality (CQ) provides independent assurance that our Company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.

• →Prepares, conducts QA audits, including prolonged auditing in China, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.

• →Collaborate with colleagues in China to understand cultural considerations, responsibilities for work in global studies and local regulations in the China related to GCP and new drug applications.

• →Able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risk-based audits.

• →GCP routine and directed audits of investigator sites, country offices, suppliers, , third party collaborations and due diligence activities.

• →In alignment with risk assessments and input from Japan/China Lead, support the QALs in the identification of audit substrate in China for scheduling, as appropriate.

• →Ability to travel to/within China; extended stay in country (2-3 weeks per quarter).
• →Travel: 75% - Asia Pacific (China), including ROW as needed.

• →Bachelor's degree (BS/BA) or equivalent preferred.
• →Minimum of 5 years of experience in a relevant field.

#eligibleforERP

• Facilitates communication and alignment with key stakeholders related to quality events and audit findings.
• Participate in Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as deemed appropriate by the QAL.
• Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.