Global Product Quality Reporting Lead

6010-Biosense Webster Inc. Legal Entity; Schaffhausen; On-site; CHF 150,000 - 210,000; Full time

Job summary

Johnson & Johnson in Schaffhausen, Switzerland seeks a Global Process Owner for Product Quality Reporting within the Innovative Medicine Quality organization. This role drives BPDR, FAR, APR, and PQR processes across a global matrix, partnering with regulatory, platform quality, and site teams to ensure compliant, data-driven product quality governance.

The position emphasizes global standardization, data governance, and continuous improvement, with responsibility for inspection readiness and

Qualifications

• Bachelor's degree in a life sciences, engineering or related field.
• 12+ years of experience in pharma/regulated environments.
• Strong knowledge of global GxP and cGMP requirements.
• Experience leading global, cross-functional quality programs in a matrix environment.

Responsibilities

• Own end-to-end BPDR/FAR and APR/PQR process architecture, governance, and lifecycle for IM.
• Provide global leadership for BPDR/FAR and ensure timely, compliant filings and decisions.
• Lead APR/PQR governance for end-to-end product quality review processes.
• Integrate product-quality insights across BPDR/FAR, APR/PQR, complaints, investigations, and CAPA.
• Drive a unified, globally consistent process framework with scalable controls.

Skills

BPM leadership

Regulatory compliance

GxP knowledge

Data analytics

Stakeholder engagement

Process governance

ISO 9001

Change management

Quality systems

Project management

Education

Bachelor's degree

Job description

Johnson & Johnson in Schaffhausen, Switzerland seeks a Global Process Owner for Product Quality Reporting within the Innovative Medicine Quality organization. This role drives BPDR, FAR, APR, and PQR processes across a global matrix, partnering with regulatory, platform quality, and site teams to ensure compliant, data-driven product quality governance.

The position emphasizes global standardization, data governance, and continuous improvement, with responsibility for inspection readiness and