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Protecting against emerging global health threats.
Director, Global Quality Systems Governance
Location
Maryland
Posted
60 days ago
Salary
$178.5K - $216K / year
Seniority
Lead
Job Description
Director, Global Quality Systems Governance
Emergent BioSolutions
• Overseeing and supporting the global process owners for the primary global quality management systems including deviations, CAPA, Change Control, Training, Document Control • Implementing and delivering continuous improvement to the global quality management system • Driving change management across the network to achieve standardization / harmonization of practices across the network • Collaboration with other global process owners to ensure overall quality system remains contemporaneous and fit for use for the network • Lead cross functional teams to ensure continuous improvement of the governing QMS framework processes and related technologies • Hire, develop, and retain quality personnel to create a high-performing capable team
Job Requirements
- Bachelor’s Degree level in science, statistics, or math
- Advanced degree and/or MBA preferred
- Minimum ten (10) years of experience in the Biopharma/Pharmaceutical industry with cross-functional experience
- Excellent understanding of Quality Management System philosophies
- Excellent leadership, interpersonal, communication, negotiation, and problem-solving skills
- Sound understanding of regulated activities, health authority expectations, and GxP
- Excellent organizational awareness, including significant experience working cross-functionally and in global, cross-cultural teams
- Experience developing and executing large-scale organizational change, including change management strategy and planning
- Proven ability to understand complex processes/problems and facilitate/coach teams to optimal solutions
- Ability to implement global business processes/policies with a critical thinking approach and enterprise mindset
- Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics
- Experience in leadership and support of an organizational culture that promotes and sustains quality as an element of superior business performance
- Excellent written and oral communication abilities
- Extensive experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint)
- Ability to effectively maintain a culture of continuous improvement is essential.
Benefits
- Comprehensive benefits package
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