Global Process Owner: Product Quality Reporting Leader

Johnson Johnson; Raritan (NJ); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year

Holiday pay – 13 days per year

Parental Leave – 480 hours per year

Volunteer Leave – 32 hours per year

Job summary

Johnson & Johnson is seeking a Global Process Owner in Product Quality Reporting to lead end-to-end BPDR/FAR and APR/PQR processes across IM quality. The role coordinates with sites, Platform Quality, Regulatory, and DS teams to drive standardization, data governance, and remediation actions.

The position requires 12+ years in regulated industries, a Bachelor's degree, and strong strategic, analytical, and cross-functional leadership capabilities to ensure inspection readiness and continual

Qualifications

• Bachelor's degree in a related discipline required.
• At least 12 years of experience in a regulated industry (pharma/biotech/medical devices).
• Knowledge of global GxP and cGMP requirements.
• Experience leading global, cross-functional programs in a matrix environment.
• Ability to define strategy and translate it into executable plans and governance.
• Strong communication, negotiation, and analytical skills.

Responsibilities

• Own end-to-end BPDR/FAR and APR/PQR process architecture and governance.
• Provide global process leadership for BPDR and FAR filings.
• Set direction for APR/PQR execution and follow-up on improvements.
• Integrate product-quality signals to strengthen risk identification.
• Drive a globally consistent process framework with local/regulatory variations.
• Define and analyze process KPIs for governance forums.
• Lead digital/data roadmap and analytics enablement.
• Develop global Community of Practice and process capability.

Skills

Global process ownership

BPDR/FAR governance

APR/PQR governance

Process standardization

Data governance

Stakeholder collaboration

Quality governance

Matrix leadership

Change management

Education

Bachelor's degree required

Job description

Johnson & Johnson is seeking a Global Process Owner in Product Quality Reporting to lead end-to-end BPDR/FAR and APR/PQR processes across IM quality. The role coordinates with sites, Platform Quality, Regulatory, and DS teams to drive standardization, data governance, and remediation actions.

The position requires 12+ years in regulated industries, a Bachelor's degree, and strong strategic, analytical, and cross-functional leadership capabilities to ensure inspection readiness and continual