Associate Director – Quality Assurance

🔥 0 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $129k - $203.1k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• 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

• 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

• 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