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:
Toronto, Ontario, Canada

Job 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 #

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 ...