Senior Quality Systems Analyst – Global Impact & Compliance

Johnson & Johnson Innovative Medicine; Raritan (NJ); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson is currently recruiting a Senior Analyst, Quality Systems to be located in Raritan, NJ. This role focuses on maintaining and improving quality systems, documents, data integrity, and cGMP compliance within the Advanced Therapies and Innovative Medicine teams.

You will collaborate across global sites, support audits and investigations, and lead selected projects through to closure while updating SOPs and aligning local and global processes.

Qualifications

• Minimum 4 years of related work experience.
• Experience in Quality Assurance/Quality Systems.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Strong written and verbal communication skills in English.

Responsibilities

• Provide preliminary guidance and execute quality system activities, including but not limited to Document/Records Management and Data Integrity.
• Act as a liaison between Raritan Advanced Therapies (AT) site and AT platform/Innovative Medicine level activities.
• Support document lifecycle at Raritan AT.
• Perform Raritan AT superuser activities.
• Elevate identified quality systems risks to senior management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGxP requirements.
• Actively assist in audit activities, Investigations and Change Controls.
• Identify improvement opportunities for quality systems activities.
• Participate in department optimization effort, take the lead on selected projects assignments following them through closure.
• Update Standard Operating Procedures or related documents as needed.
• Drive alignment and efficiencies between local and global processes through building positive relationships to meet unified business objectives.
• Other duties can be assigned to support business continuity.

Skills

Quality Systems

cGMP knowledge

Written and verbal English

Global collaboration

Education

Bachelor’s degree in engineering or science

Job description

Johnson & Johnson is currently recruiting a Senior Analyst, Quality Systems to be located in Raritan, NJ. This role focuses on maintaining and improving quality systems, documents, data integrity, and cGMP compliance within the Advanced Therapies and Innovative Medicine teams.

You will collaborate across global sites, support audits and investigations, and lead selected projects through to closure while updating SOPs and aligning local and global processes.