Global Head of Quality Systems
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The Global Head of Quality Systems is a strategic, high-impact role designed to maximize efficiency, effectiveness, and alignment across the enterprise. The role will act as an integrator across global functions, a project leader for cross-functional Quality initiatives, and a trusted advisor to the CQO. This role supports the execution of the quality strategy, drives operational excellence, and ensures alignment across GMP manufacturing facilities.
Job Responsibilities
Strategic & Operational Support
- Serve as a thought partner to the CQO in shaping and implementing the global Quality strategy.
- Drive prioritization, planning, and execution of key initiatives across the Quality Management System (QMS), compliance, and site performance.
- Track and manage the CQO’s key deliverables, ensuring alignment with executive and board-level expectations.
Program & Project Management
- Lead cross-functional Quality programs such as harmonization of Quality systems, data governance, metrics standardization, audit readiness, and inspection preparedness.
- Monitor progress on strategic initiatives across sites and escalate risks or delays proactively.
- Ensure readiness for major initiatives (e.g., new facility readiness, tech transfers, remediation, system upgrades).
Communications & Alignment
- Develop clear and consistent communications from the CQO to internal and external stakeholders, including board materials, strategy decks, and site engagement updates.
- Facilitate effective meeting cadences (e.g., QBRs, site quality forums, leadership team meetings) and prepare briefing materials.
- Foster alignment between the CQO’s office and site heads of Quality, Regulatory, and Operations.
Operational Excellence & Performance Tracking
- Support deployment of quality metrics and KPIs across the network; drive continuous improvement and benchmarking.
- Coordinate follow-up on audit and regulatory commitments and track closure of CAPAs.
- Support integration of digital tools and analytics in quality operations.
Qualifications
Education
- Bachelor's degree in a scientific or technical discipline or equivalent years of experience; advanced degree (e.g. MS, PharmD, MBA) preferred.
Experience
- 15+ years in the pharmaceutical or biopharmaceutical industry, with at least 8 years in Quality leadership roles within a GMP manufacturing environment.
- Experience in sterile injectable manufacturing and/or CDMO operations strongly preferred.
- Prior experience supporting executive leadership or working in a Chief of Staff or strategic PMO capacity a plus.
Skills
- Strong project management and organizational skills.
- Excellent communication and analytical abilities.
- Ability to influence without authority, and strong stakeholder management.
- Understanding of global regulatory expectations (FDA, EMA, MHRA, etc.) and QMS frameworks.
#LI-Remote
Other details
- Pay Type Salary
- Min Hiring Rate £183,000.00
- Max Hiring Rate £242,000.00
- 11200 Hudson Rd, Woodbury, MN 55129, USA
- Virtual