External Quality Operations Sr. Analyst

External Quality Operations Sr. Analyst

Johnson and Johnson Innovative Medicine is recruiting for an 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.