Sr. Account Specialist, External Quality (EQ)

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:

Malvern, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Sr. Account Specialist, External Quality (EQ) to be located in Malvern, PA or Titusville, NJ.

This position will provide QA technical support for External Manufacturers (EM) in the Americas. Review and approve quality system documents including SOP, specification and manufacturing instructions. Responsible for product release, ensuring products meet cGMP, Janssen specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety. Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required. Responsible for continuous improvement and risk management activities of EM.

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 processes and development of robust CAPA plans.

• Review and approve quality system documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.

• Monitor quality performance, identifying trends, and support the development of appropriate mitigation plans.

• Establish relationships with internal and external partners, influence external manufacturers to continuously improves 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 transfers and new product introduction activities, support associated heath authority filings.

• Participate and support escalation process and issue management process.

• Maintain Quality Agreement and specification changes.

• Travel to the EM site to provide on-site GMP oversight and support as need

Qualifications

Education:

• A minimum of a Bachelor’s degree in Science, Engineering and/or Technical field is required.

Experience and Skills

• A minimum of 4 years working in an FDA regulated environment is required.

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Excellent computer proficiency e.g. MS Office, SAP, required Quality Systems

• Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

• Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and manufacturing.

• Remaining current with FDA and local regulations, guidelines, and quality practic