Global Quality Manager
Patients receive a product only after quality has already done its work. This role sets the standard for how that work is done across regions, sites, and partners—so every batch released is safe, consistent, and defensible. You will turn a science- and risk-based quality culture into measurable outcomes: fewer repeats, cleaner inspections, and faster, compliant supply. The work matters because a missed signal or a weak system does not stay local; it reaches the people who depend on the medicine.
Performance Objectives
- Stand up one global quality system that keeps marketed and pipeline products inspection-ready across all operating regions.
- Cut repeat deviations and ineffective CAPA by at least 30% within 12 months, with effectiveness verified, not just closed.
- Lead health-authority inspections to successful outcomes, with no major observations tied to system design or governance gaps.
- Hold on-time, right-first-time batch release at agreed service levels without trading compliance for speed.
- Harmonize standards for manufacturing, laboratories, and external partners so quality decisions are consistent market to market.
- Install early-escalation routines so critical risks are visible to leadership before they become supply or patient events.
- Develop site quality leaders who run local systems independently against the global standard.
Environment & Resources
You report to the head of Global Quality and work in a matrix with site heads, Analytical R&D, manufacturing, supply, regulatory, and medical. A small central team and designated site quality leads are yours to direct. You own the quality management system, deviation and CAPA governance, and a defined audit and inspection budget. Travel is planned around inspections, site reviews, and partner oversight—not constant presence. Decisions are risk-based, documented, and made with the people who must live with them.
Essential Qualifications
- Bachelor’s degree in a scientific or engineering discipline; advanced degree or recognized quality certification preferred.
- 8+ years in pharmaceutical or biopharmaceutical quality, including multi-site or multi-country GMP accountability.
- A record of leading inspections and remediating findings so they do not recur.
- Hands-on ownership of deviation, CAPA, change control, and batch-disposition decisions under GMP.
- Ability to influence site and functional leaders who do not report to you, and to hold a standard when speed is the pressure.
- Clear written and spoken communication for regulators, executives, and shop-floor teams.
Role Selling Points
- Quality is treated as how products reach patients, not as a back-office control function.
- Global scope with real authority over the system, not a coordination title.
- Cross-functional seat with R&D, supply, and commercial when tradeoffs affect patients or compliance.
- Room to build leaders and simplify a complex quality landscape rather than add process for its own sake.
- A purpose-led culture that expects ownership, candor, and results you can measure.
Call to Action
If you have held a global quality standard under inspection pressure and can show the outcomes, apply. Bring the record. We will talk about what you will deliver in the first year.