Manager External Quality Small Molecules

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:

Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, External Quality (Small Molecules)! This position can be performed in Titusville, NJ, Horsham, PA, Athens, GA or Toronto, Ontario CA.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

North America- Requisition #R-016448

Canada- Requisition #R-017597

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

In this position you will provide end to end quality oversight 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 leadership and technical support to ensure effective execution of quality systems at external manufacturing sites
• Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners
• Support the identification and resolution of quality issues and complaints, including facilitation of 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 through the development of 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.
• Collaborate with external manufacturers to support health authority inspections; monitor and follow-up on associated response and commitments.
• Provide oversight for tech transfer and new product introduction activities.
• Support risk management initiatives necessary to improve performance.

Qualifications:

Education:

• A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred.

Experience and Skills:

Required:

• A minimum of 8 years working in a GMP regulated environment.
• Experience with quality support of clinical and commercial manufacturing operations.
• Experience managing quality oversight for pharmaceutical production.
• 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.
• Experience working on cross-functional project teams.
• Strong communication, influencing and leadership skills, demonstrating an ability to communica