EQ Quality Operations Sr. Analyst

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:

Latina, Italy

Job Description:

Johnson and Johnson Innovative Medicine is recruiting for a Quality Operations Sr. Analyst EQ (External Quality) reporting to the Manager External Quality Operations.

Essential Job Duties and Responsibilities

This position will focus on end-to-end support for EQ Escalations management. Key responsibilities include managing records throughout the entire process in COMET (Salesforce), facilitating meetings to drive resolution, and offering guidance to Issue Owners on escalation procedures and requirements. All activities will be conducted in strict adherence to global Innovative Medicine procedures.

Additionally, this position supports general tactical execution of centralized External Quality Operations activities, which may include:

• Generation and management of Reports for the relevant Quality processes
• Subject Matter Expertise and user support in tactical execution within electronic Quality Systems
• GMP Documentation support for EQ
• Technical support for Training management for EQ
• Prepare and share monthly metrics reports
• Support preparation and publishing of APR/PQR schedules
• Coordination of the team's tasks.

Exact activities may evolve based on further centralization of operational tasks within the External Quality organization.

This position will support internal and external audits and inspections.

Minimum Qualification

• Minimally basic degree in Science, Engineering and Technical subjects, or equivalent.
• Previous working experience in Quality in a GMP environment.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency e.g MS Office
• Excellent analytical skill 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.
• Demonstrates ability to build and nurture strong, positive relationships with stakeholders
• Demonstrates understanding of regulatory requirements that impact Quality Systems specifically, and external manufacturers and JSC more broadly.
• Problem-solving abilities and issue resolution abilities within regulatory constraints.
• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
• Fluent knowledge of English language