Global Product Quality Reporting Leader

Johnson Johnson; Horsham (PA); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40-56 hours/year (state dep)

Holiday pay 13 days/year

Parental Leave 480 hours/year

Job summary

Johnson & Johnson is seeking a Global Process Owner (GPO), Product Quality Reporting, for Innovative Medicine Quality, to lead BPDR/FAR and APR/PQR programs across Titusville, NJ; Raritan, NJ; or Horsham, PA. The role drives end-to-end governance, data-driven insights, and standardized processes across a global matrix.

The GPO will partner with sites, Regulatory, MSAT and platform teams to deliver compliant, inspection-ready analytics and continuous improvement through global process

Qualifications

• Bachelor’s degree required; fields in pharmacy, chemistry, engineering, life sciences, statistics or related discipline preferred.
• At least 12 years of experience in pharmaceutical/biotech or similarly regulated industries with QA and/or regulatory compliance experience.
• Strong knowledge of global GxP and cGMP; experience translating requirements into sustainable global processes.
• Experience leading complex global cross-functional programs or Quality System processes in a matrix environment.
• Ability to identify and manage GxP compliance risk and develop remediation strategies.
• Excellent analytical, decision-making, influencing, negotiation, and communication skills.

Responsibilities

• Own end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards and lifecycle for IM.
• Provide global process leadership for BPDR and FAR, including governance and filing decisions.
• Act as the global process owner for APR/PQR execution and reporting.
• Connect signals across BPDR/FAR, APR/PQR, investigations, CAPA, and CPV to strengthen risk insights.
• Drive one globally consistent process framework while allowing justified local/regulatory variation.
• Define and monitor process KPIs and quality metrics for governance forums.
• Own data governance for enabling systems, analytics, and reporting.
• Lead the global Community of Practice and drive process capability and adoption.

Skills

GxP knowledge

Regulatory compliance

Cross-functional leadership

Data analytics

Process ownership

Global program management

Communication skills

Education

Bachelor's degree in a related field

Tools

Quality Management System (QMS)

Job description

Johnson & Johnson is seeking a Global Process Owner (GPO), Product Quality Reporting, for Innovative Medicine Quality, to lead BPDR/FAR and APR/PQR programs across Titusville, NJ; Raritan, NJ; or Horsham, PA. The role drives end-to-end governance, data-driven insights, and standardized processes across a global matrix.

The GPO will partner with sites, Regulatory, MSAT and platform teams to deliver compliant, inspection-ready analytics and continuous improvement through global process