Director, Global Quality Systems Governance

Emergent Biosolutions

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About The Position

Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed
by our values and commitment to protecting and saving lives.Job Summary
The Director, Global Quality Management Systems is responsible for the delivery and execution of the Global Quality Management Systems in support of the overall quality Strategy. This role is responsible for providing technical input into the implementation and helping to drive continuous improvement of the GxP Quality management Systems to ensure they are contemporaneous and right sized for the organizational needs. This role will report directly to the VP Quality, Enterprise GxP Compliance and Systems.

Requirements

• Bachelor’s Degree level in science, statistics, or math. Advanced degree and/or MBA a preferred.
• Minimum ten (10) years of experience in the Biopharma/Pharmaceutical industry with cross-functional experience.
• Should have an 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees