Director, Global Quality Systems Governance
Emergent BioSolutions
full-time
Posted on:
Location Type: Remote
Location: Maryland • United States
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Salary
💰 $178,500 - $216,000 per year
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management SystemChange ManagementContinuous ImprovementDocument ControlCAPADeviationsTrainingStatistical AnalysisProblem SolvingProcess Optimization
Soft Skills
LeadershipInterpersonal CommunicationNegotiationOrganizational AwarenessCross-Functional CollaborationCritical ThinkingCoachingCommunicationTeam DevelopmentStakeholder Management