Skills

Communication Salesforce Quality Assurance Problem-solving Training Organization Analytical Skills

Job Specifications

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:

Beerse, Antwerp, Belgium, Cork, Cork, Ireland, Latina, Italy, Milano, Italy, Schaffhausen, Switzerland

Job Description

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

Essential Job Duties And Responsibilities

This position will mainly focus on end-to-end support for External Quality Escalations management. Key responsibilities include: providing guidance to Account Owners and Quality Heads on Quality and Compliance Escalation procedures and requirements, facilitating Escalation meetings to drive resolution, managing records throughout the entire process in COMET (Salesforce).

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.
A minimum of 5 years of previous working experience in Quality in a GMP environment.
Previous experience in escalating quality issues is preferred.
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers including higher management.
Ability to lead/coordinate meetings to resolve discussions to reach agreements.
Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution.
Excellent computer proficiency e.g MS Office
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.

About the Company

At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients ev... Know more