Global IM CSV Quality Leader
Johnson & Johnson Innovative Medicine
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Benefits offered by this job
Job summary
Johnson & Johnson Innovative Medicine seeks an IM CSV Quality Lead to drive validation strategy, governance and lifecycle oversight for GxP systems. You will ensure compliance with Annex 11, 21 CFR Part 11 and data integrity standards across IM platforms, leading a global network of CSV leads and collaborating with QA, IT, and manufacturing teams.
You will shape risk-based validation programs, manage system lifecycle activities, and mentor project teams to maintain validated states while
Qualifications
- Extensive CSV experience in a GxP-regulated environment.
- Proven leadership in global or cross-site roles.
- Strong communication and stakeholder management skills.
- Working knowledge of Annex 11, 21 CFR Part 11 and ISO requirements.
Responsibilities
- Act as CSV lead, ensuring timely communication of quality issues to senior stakeholders.
- Lead CSV strategy, governance, and lifecycle validation activities.
- Develop risk-based validation approaches and quality risk management.
- Oversee data integrity practices (ALCOA+) across IM systems.
Skills
Education
Job description
Johnson & Johnson Innovative Medicine seeks an IM CSV Quality Lead to drive validation strategy, governance and lifecycle oversight for GxP systems. You will ensure compliance with Annex 11, 21 CFR Part 11 and data integrity standards across IM platforms, leading a global network of CSV leads and collaborating with QA, IT, and manufacturing teams.
You will shape risk-based validation programs, manage system lifecycle activities, and mentor project teams to maintain validated states while
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