Global Product Quality Reporting Leader

Johnson & Johnson Innovative Medicine

Schaffhausen

On-site

CHF 180,000 - 260,000

Full time

8 days ago

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Job summary

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland seeks a Global Process Owner, Product Quality Reporting, to lead end-to-end BPDR/FAR and APR/PQR processes within IM Quality. This role involves defining governance, data-driven insights, and cross-site collaboration to ensure regulatory readiness and continuous improvement.

The role requires extensive QA/regulatory experience, global process ownership, and strong stakeholder management to drive standardized, compliant workflows

Qualifications

Minimum of a Bachelor’s degree in a relevant field.
At least 12 years of QA/Regulatory experience.
Knowledge of global GxP and cGMP requirements.
Experience leading complex global programs in a matrix.
Experience managing GxP compliance risk and remediation.
Strong analytical and decision-making skills.
Excellent written and verbal communication.

Responsibilities

Own BPDR/FAR and APR/PQR process architecture and governance.
Provide governance for BPDR and FAR filings.
Lead APR/PQR governance and execution.
Develop integrated product-quality insights across inputs.
Drive global standardization and simplify workflows.
Define KPIs and management-review reporting.
Lead process-owner network and capability development.

Skills

Analytical thinking

Decision making

Influencing

Negotiation

Written communication

Verbal communication

Education

Bachelor’s degree

Advanced degree

Job description

The role requires extensive QA/regulatory experience, global process ownership, and strong stakeholder management to drive standardized, compliant workflows

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