Manager, External Quality

Job Title

Manager, External Quality

Provide quality leadership and oversight of external manufacturers in the North America region, ensuring consistent delivery of pharmaceutical drug substance that meets or exceeds safety, regulatory compliance, and product standards. Work closely with External Manufacturing, Quality and Compliance functions, Internal J&J sites, Product Quality Management, and Global Manufacturing Science and Technology.

• Ensure effective and compliant execution of quality systems at external manufacturing (EM) sites.
• Build relationships with internal and external partners emphasizing Operational Excellence, Trust & Transparency, Agility & Resiliency, Partnership, and Innovation.
• Prepare EMs for successful health authority inspections; identify regulatory compliance risks, and follow up on related commitments.
• Provide oversight for technology transfer and new product introduction activities; lead PAI readiness and support associated health authority filings and approvals.
• Participate in the onboarding, qualification, and ongoing monitoring of external partners.
• Partner with manufacturing sites and quality counterparts to identify and resolve quality issues and complaints, including developing robust CAPA plans and effectiveness checks.
• Review and approve product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.
• Contribute to process mapping of key quality systems to identify and implement innovative ways of working.
• Monitor quality performance through tracking of key performance indicators.
• Partner with key internal stakeholders in support of supply chain to meet patient supply requirements.
• Assess current quality systems and recommend improvements to enhance compliance and optimize processes.

• A minimum of a Bachelor’s or equivalent University Degree; focus in engineering, science, or an equivalent technical discipline preferred.
• Minimum of 8 years working in QA and/or QC functions in the 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.
• Full‑time role located in Holly Springs, North Carolina.
• Remote‑hybrid with an expectation of 3 days in‑office at the manufacturing site in Holly Springs, North Carolina and up to 2 days remote work per week.
• May require up to 10% domestic travel.

Horsham, Pennsylvania;
North Carolina (Any City);
Raleigh, North Carolina;
Holly Springs, North Carolina.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-) or contact AskGS to be directed to your accommodation resource.