Sr Specialist, External Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson Innovative Medicine, is recruiting for a Sr. Specialist, External Quality (Small Molecules). The preferred location for this position will be in Horsham, PA or Titusville, NJ. However, the role can also be located in Athens, GA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.  

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

In this position you will provide end-to-end quality support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:

• Provide quality and technical support to ensure effective execution of quality systems at external manufacturing sites.
• Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans. Support the escalation and issue management processes.
• Review and approve quality systems documentation, including batch documentation and product disposition, change controls, manufacturing instructions, quality agreements, specifications, validation documentation, and technical studies.
• Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.
• Build relationships with internal and external partners to meet patient supply requirements.
• Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture. Support risk management initiatives necessary to improve performance. Write and implement quality procedures and work instructions.
• Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments.
• Provide quality oversight for tech transfer and new product introduction activities. Support a variety of projects both internally and with external manufacturers.
• Act as a backup to External Quality account owners in support of external manufacturers as needed.

Qualifications

Education:

• A minimum of a Bachelor's or equivalent University degree is required; a focus in Life Science, Engineering or Physical Science is preferred.

Experience and Skills

Required:

• A minimum of 5 years working in a cGMP regulated environment.<