Hybrid Manager, External Quality

at Johnson & Johnson

• Job title: Manager, External Quality
• Job type: Full Time
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Holly Springs, United States

About the role

• Manager, External Quality responsible for oversight of pharmaceutical manufacturing processes in North America. Ensuring quality compliance and building partnerships with external manufacturers.

Responsibilities

• Provide quality leadership and oversight of external manufacturers in the North America region.
• Ensure effective and compliant execution of quality systems at external manufacturing (EM) sites.
• Build relationships with internal and external partners.
• Prepare EMs for successful health authority inspections.
• Provide oversight for technology transfer and new product introduction activities.
• Participate in the onboarding, qualification, and ongoing monitoring of external partners.
• Partner with manufacturing sites to identify and resolve quality issues.
• Review and approve product disposition and documentation.
• Monitor quality performance through tracking of key performance indicators.
• Assess current quality systems and recommend improvements.

Requirements

• A minimum of a Bachelor’s or equivalent University Degree is required with a focus in engineering, science, or an equivalent technical discipline preferred.
• A minimum of 8 years working in QA and/or QC functions in pharmaceutical industry.
• Experience in biotherapeutic manufacturing.
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
• Experience with manufacturing-facing support of clinical or commercial manufacturing operations.
• Ability to work independently in support of a portfolio of products and suppliers.
• Ability to quickly process complex information and make critical decisions with limited information.
• Strong interpersonal, communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization.
• Experience with cell culture, biotherapeutic drug substance manufacturing preferred.
• Experience working with external manufacturers preferred.
• Experience developing or reviewing electronic batch records preferred.
• Experience in development or application of digitally-integrated quality metrics preferred.

Benefits

• Equal Opportunity Employer
• Inclusive work environment
• Health insurance
• Professional development opportunities