Senior Analyst, Business Process Quality

At Johnson & Johnson Innovative Medicine (IM), we are committed to delivering transformative treatments that improve patient lives worldwide. We strive to set new standards in quality and excellence through innovation and collaboration.

Product Quality Management (PQM) plays a critical role in ensuring the highest standards of quality across our products. We are seeking a Senior Analyst, Business Process Quality to join our team, contribute to this mission, and make a significant impact on product quality and operational excellence.

This is a global position, preferably located at one of our major JJIM manufacturing sites

The Senior Analyst, Business Process Quality will be part of the Product Risk Management and PQM Support team, within Strategy Deployment & Excellence in PQM. The role involves ownership of selected Quality Management System (QMS) processes and provides essential support to PQM and other organizations across IM Supply Chain, IM Quality, and Therapeutics Development & Supply (TDS). Key responsibilities include managing processes related to budgeting, resource planning, and reporting, while ensuring compliance and driving continuous improvement.

Key Responsibilities:

Quality Systems

• Serve as PQM process owner for selected QMS processes, including Internal Audits.
• Provide back-up support for other systems such as NC/CAPA, Change Control, Document Management, and Training.
• Assume additional ownership of tactical support systems over time (e.g., COMET STAR user), ensuring compliance, system access, and oversight.
• Actively participate in councils and forums related to QMS processes.
• Continuously improve processes and systems to enhance efficiency and effectiveness.
• Support Quality Review Meetings, metrics, and dashboards for PQM and TDS.

Business Support

• Provide budget support for PQM, including headcount oversight, LRFP, and BP planning (currently for PQM-base and ECSQ), in alignment with other team members.
• Support onboarding and training of new team members as well as document management and training activities to maintain PQM’s operational continuity.

Qualifications

Education

• Bachelor’s degree required, preferably in Pharmaceuticals, Chemistry, Engineering, Sciences, or a related field.

Experience and Skills:

Required:

• Proven experience in a regulated industry (pharmaceuticals, medical devices, biotechnology), preferably in Quality Assurance or Quality Engineering.
• Experience in supporting or leading audits, NC/CAPA and/or change control activities.
• Familiarity with budget and business support activities, including relevant systems and tools.
• Strong written and verbal communication skills, with the ability to clearly present quality risks, decisions, and recommendations to cross-functional partners.
• Demonstrated ability to manage multiple priorities, work independently, and adapt in a dynamic environment.
• Global mindset with collaboration and relationship-building capabilities.
• Ability to identify, influence, and implement effective solutions.
• Fluency in English

Preferred:

• Experience in managing internal and external audits, including preparation, participation, and response development.
• Knowledge of Business Process Management, Six Sigma, compliance management, and financial planning.
• Technologically savvy and data-driven approach.

Hybrid Work