Global Process Owner, PQ Reporting

Johnson Johnson; Titusville (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a Global Process Owner for Product Quality Reporting to lead end-to-end BPDR, FAR, APR, and PQR processes within Innovative Medicine Quality. This role will coordinate with sites in Titusville, NJ; Raritan, NJ; and Horsham, PA, guiding governance and data-driven quality initiatives across a global matrix.

You will drive standardization, analytics, and compliance, partnering with Regulatory, Quality, and platform teams to ensure robust product quality governance.

Responsibilities

• Global process ownership: Own the end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for IM.
• BPDR/FAR governance and filing decisions: Provide global process leadership for BPDR and FAR with governance and decision framework.
• APR/PQR governance: Act as the global process owner for the end-to-end Product Quality Review / APR/PQR process.
• Integrated product-quality insight: Connect signals across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA and more to identify risks.
• Standardization and simplification: Drive a globally consistent framework and simplify workflows and handoffs across sites and functions.
• Metrics, management review, and effectiveness: Define and analyze KPIs and quality metrics for governance forums.
• Digital, data, and analytics enablement: Own data governance and requirements for enabling systems, analytics, and reporting.

Job description

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for Global Process Owner (GPO), Product Quality Reporting to join our Innovative Medicine Quality organization located in Titusville, NJ; Raritan, NJ; or Horsham, PA.Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):Switzerland– RequisitionNumber:R-104906Belgium– RequisitionNumber: R-104913 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Global Process Owner (GPO), Product Quality Reporting, provides Innovative Medicine (IM) end-to-end ownership, governance, and strategic direction for Biological Product Deviation Reporting (BPDR), Field Alert Reporting (FAR), Annual Product Review (APR), and Product Quality Review (PQR). The role establishes a single, sustainable operating framework that connects regulatory reporting, periodic product review, product-risk insight, and Quality governance across the product lifecycle. Working through a global matrix, the GPO drives compliant and consistent process execution, clear decision rights, standardized data and analytics, digital enablement, process performance, inspection readiness, and continuous improvement. The role partners with sites, Platform Quality, Enterprise Quality, Regulatory, IM Regulatory Compliance, product and process owners, technology teams, and other stakeholders while execution remains with the accountable business and site organizations.

Core Accountabilities:

• Global process ownership: Own the end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for IM. Establish clear scope, decision rights, roles and responsibilities, interfaces, controls, escalation pathways, and execution expectations.
• BPDR/FAR governance and filing decisions: Provide global process leadership for BPDR and FAR. Establish the governance and decision framework needed to support timely, consistent, traceable, and compliant assessments and filings. Serve as, or formally designate through approved governance, the ultimate process-level filing decision authority, consistent with applicable procedures and delegated accountability.
• APR/PQR governance: Act as the global process owner for the end-to-end Product Quality Review / Annual Product Review process. Set direction for sustainable global execution, including data gathering, holistic product review, interpretation of data and trends, risk identification, reporting, review, approval, and follow-through on improvement opportunities.
• Integrated product-quality insight: Connect signals and outputs across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA, escalation, continued process verification, stability, and other relevant inputs to strengthen proactive product-risk identification and management.
• Standardization and simplification: Drive one globally consistent process framework while defining the controls needed for justified local or regulatory variation. Simplify workflows, reduce ambiguity, improve traceability, and clarify handoffs among global, regional, platform, site, and functional teams.
• Metrics, management review, and effectiveness: Define, maintain, and analyze process KPIs and quality/compliance metrics, including timeliness, status, quality of execution, trends, recurring issues, and effectiveness. Ensure meaningful process insights are available for the appropriate management-review and Quality governance forums.
• Digital, data, and analytics enablement: Own business requirements and end-to-end data governance for enabling systems, automation, analytics, and reporting. Partner with