VP Global Process Management
Listed on 2026-07-10
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Position Summary
The Vice President, Global Process Management, Quality Management & Digital is responsible for leading 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 process harmonization, and ensures Quality processes and systems 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 with cross‑functional leaders to align Quality process strategy with business priorities and regulatory expectations.
- 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 and eQMS optimization (workflow design, data standards, system requirements, user roles, inspection‑ready documentation).
- Establish and monitor global Quality performance metrics, dashboards, and management review mechanisms.
- Support regulatory inspections, audits, and remediation by ensuring process design/governance/execution meet requirements.
- Lead global councils, communities of practice, and change‑management for adoption and sustained process performance.
- Bachelor’s in Life Sciences/Engineering/Pharmacy or related field (advanced degree preferred).
- 15+ years’ experience in highly regulated industries (pharma/biotech/medical devices).
- Significant global leadership in Quality/Quality Systems/Compliance.
- People management 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/eQMS, data integrity, global data standards, and inspection readiness.
- Preferred: enterprise Quality transformation, Lean/Six Sigma/operational excellence, communities of practice, strong digital fluency (automation/analytics/AI/ML/predictive quality).
20%–30% domestic and international travel.
BenefitsVacation: 120 hours/year;
Sick time: 40 hours/year (CO 48; WA 56);
Holiday pay (including Floating Holidays): 13 days/year;
Work/Personal/Family Time: up to 40 hours/year.
Parental Leave: 480 hours (within one year of birth/adoption/foster care);
Bereavement Leave: 240 hours immediate family; 40 hours extended family/year.
Caregiver Leave: 80 hours in a 52‑week rolling period (10 days);
Volunteer Leave: 32 hours/year;
Military Spouse Time‑Off: 80 hours/year.
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