Director, External Quality

🔥 5 minutes ago

🌲 North Carolina, Pennsylvania – Remote

🌲 North Carolina – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🔴 Lead

👔 Director

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Leading a team of quality professionals ensuring compliance and quality oversight across external manufacturing of products and devices • Subject matter expert in EQA and manufacturing quality systems, technology platforms, regulatory expectations, and external manufacturing management • Represent the company in external forums • Lead complex cross-functional initiatives to optimize quality and business processes driving continuous improvement • Act as a subject matter expert for both EQA and the manufacturing division in specific Quality Systems • Collaborate with other functions to continuously improve effectiveness and efficiency in quality management and quality systems

🎯 Requirements

• Minimum four-year degree in Science, Engineering, or other relevant technical discipline • Minimum of 12 years relevant experience in the Pharmaceutical and/or Medical Device industry • Thorough knowledge of Quality Systems, Quality Assurance, and Quality Control • Good knowledge and experience with MDCPs • Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills • Ability to work across boundaries; demonstrated interpersonal, relationship building, and leadership skills • Proficiency in English, both verbally and in writing • Previous experience participating in regulatory inspections • Familiarity with domestic and foreign regulations and compendia governing plant operations

🏖️ Benefits

• Flexible working where possible • Hybrid working model for office-based colleagues