Director, Quality Oversight – Contract Testing Laboratories

Job not on LinkedIn

🔥 0 minutes ago

🌐 United States, Netherlands, +2 more countries – Remote

🇺🇸 United States – Remote 🇳🇱 Netherlands – Remote 🇮🇪 Ireland – Remote 🇨🇭 Switzerland – Remote

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $173.2k - $272.6k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 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

• Lead strategy, organisational design, budget oversight and performance management for contract testing laboratories and the cell bank quality oversight organisation • Establish and maintain risk-based quality oversight models for contract testing laboratories and cell banking • Provide operational leadership to contract testing laboratories accountable for drug substance, drug product and finished product testing • Provide Quality oversight to ensure products are tested, stored and retained in accordance with regulatory expectations, GLP, GMP and company requirements • Oversee resolution of quality issues, out-of-specification investigations and deviations that could impact launch or supply continuity • Provide Quality oversight for analytical technology transfer • Define performance expectations, metrics and governance routines to monitor and improve quality and operational performance • Lead Quality assessments for prospective contract test laboratories or new method citing and ensure gaps are remediated • Establish and maintain Quality agreements • Direct, mentor and develop a high-performing team of quality assurance professionals • Promote accountability, collaboration, operational excellence and proactive problem-solving across internal and external testing networks

🎯 Requirements

• Bachelor’s degree in a scientific discipline required • Minimum of ten (10) years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements • Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions • Strong compliance background with experience supporting regulatory inspections and health authority interactions • Demonstrated success leading and developing teams • Ability to travel approximately 30% of the time, including occasional short-notice travel • Advanced degree in a relevant scientific or technical field preferred • Experience leading external partners across biologics or vaccines preferred • Prior leadership of a multinational organization with direct accountability for partner performance, compliance, and supply support preferred • Strong knowledge of quality governance models, supplier oversight, and risk-based quality management systems preferred • Experience partnering with leadership at external partners to influence performance, strengthen quality systems, and accelerate remediation preferred • Broader exposure to operations, engineering, supply chain, and commercial functions preferred • Experience leading transformation, standardization, or continuous improvement initiatives preferred • No visa sponsorship

🏖️ Benefits

• Annual bonus and long-term incentive, if applicable • Medical, dental, vision healthcare and other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement • No relocation