Global Quality Process Leader: BPDR, FAR & APR/PQR

Biopharma Careers; New Jersey; On-site; USD 140,000 - 210,000; Full time

Job summary

Johnson & Johnson is seeking a Global Process Owner for Product Quality Reporting to join the Innovative Medicine Quality organization, based in Titusville, NJ; Raritan, NJ; or Horsham, PA. You will own end-to-end BPDR/FAR and APR/PQR processes, ensuring governance, data integrity, and global consistency across sites and functions.

The role partners with sites, Platform Quality, Regulatory, and technology teams to drive standardization, inspection readiness, and continuous improvement in a

Qualifications

• Bachelor's degree required.
• At least 12 years in pharmaceutical/regulated industry with QA and regulatory compliance experience.

Responsibilities

• Own BPDR/FAR and APR/PQR process architecture, governance, and lifecycle for IM.
• Define global process standards, decision rights, interfaces, and escalation pathways.
• Drive data governance, analytics, and digital enablement for quality processes.
• Lead global Community of Practice and capability building for process owners.

Skills

Quality Assurance

Regulatory Compliance

Process Ownership

Pharma Industry

Education

Bachelor's degree in Life Sciences or related

Job description

Johnson & Johnson is seeking a Global Process Owner for Product Quality Reporting to join the Innovative Medicine Quality organization, based in Titusville, NJ; Raritan, NJ; or Horsham, PA. You will own end-to-end BPDR/FAR and APR/PQR processes, ensuring governance, data integrity, and global consistency across sites and functions.

The role partners with sites, Platform Quality, Regulatory, and technology teams to drive standardization, inspection readiness, and continuous improvement in a