Sr. Account Specialist, External Quality

Janssen Supply Group, a member of Johnson & Johnson Family of Companies, is recruiting for a Sr. Account Specialist, External Quality. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group is part of the Janssen Pharmaceutical Companies. This position is responsible for providing quality oversight of external manufacturers in the Americas region, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards. Key Responsibilities: Ensure effective and compliant execution of quality systems at external manufacturing sites Participate in the selection, qualification, and ongoing monitoring of external partners Provide support in the identification and resolution of quality issues and complaints, including participation in investigation process and development of robust CAPA plans Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies Monitor quality performance, identify trends, and support the development of appropriate mitigation plans Establish relationships with internal and external partners; Influence external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture Provide support for health authority inspections and follow-up on associated commitments Provide Quality oversight for tech transfer and new product introduction activities; support associated health authority filings Qualifications Education: A minimum of a University / Bachelor's Degree is required. A degree in engineering, science, or an equivalent technical discipline is preferred. Experience and Skills: Required: A minimum of 6 years of experience working in an FDA regulated industry Experience with quality oversight of clinical or commercial manufacturing operations Experience in aseptic processing Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production Strong interpersonal and written/oral communication skills Ability to quickly process complex information and make critical decisions with limited information Proficient in applying process excellence tools and methodologies Preferred: Experience in biologics manufacturing Experience working with external manufacturers Other: Available to travel up to 25% domestic travel may be required. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-New Jersey-Titusville- Other Locations United States-Pennsylvania-Horsham Organization JANSSEN SUPPLY GROUP, LLC (6046) Job Function Quality Requisition ID 2206061504W