Position Summary:
The Vice President, Global Process Management, Quality Management & Digital leads the design, standardization, governance, and continuous improvement of sector Quality processes across the global Innovative Medicine network. Establishes end-to-end process standards, drives global harmonization, and ensures Quality processes support regulatory compliance, inspection readiness, operational effectiveness, and risk-based decision-making.
Key Responsibilities:
- Lead global process ownership and governance for enterprise Quality processes (CAPA, deviations/non-conformance, change control, quality risk management, training, quality systems).
- Define and maintain global process standards, procedures, roles/responsibilities, governance forums, and performance expectations.
- Partner cross-functionally to align Quality process strategy with business priorities, regulatory expectations, and operational needs.
- Lead simplification, harmonization, and continuous improvement to reduce variability, improve cycle times, strengthen compliance, and enhance user experience.
- Provide strategic leadership for digital Quality systems/eQMS optimization (workflow design, data standards, system requirements, user roles, inspection-ready documentation).
- Establish/monitor Quality performance metrics, dashboards, and management review mechanisms.
- Support regulatory inspections, audits, and remediation through compliant process design/execution.
- Lead councils/communities of practice and change-management efforts to drive adoption and sustained performance.
Qualifications:
- Bachelorβs degree in Life Sciences, Engineering, Pharmacy, or related field required; advanced degree preferred.
- Minimum 15 yearsβ experience in pharmaceuticals/biotech/medical devices (highly regulated industry).
- Significant leadership experience in Quality/QMS/Compliance within a global regulated environment.
- People management experience required.
- Deep knowledge of GxP and global regulatory expectations (FDA, EMA, PMDA, MHRA, ICH).
- Strong QMS expertise (CAPA, deviations/non-conformance, change control, investigations, document management, training, quality risk management).
- Experience with digital Quality systems/eQMS, data integrity, global data standards, and inspection readiness.
Preferred Qualifications:
- Enterprise Quality transformation, global process ownership, or large-scale eQMS implementation.
- Lean/Six Sigma/operational excellence or structured continuous improvement.
- Building communities of practice and governance models.
- Digital fluency (automation, analytics, AI/ML, predictive quality).