The Senior Manager, Global Quality Enabling Technologies will drive execution of the Global Strategic Quality IT initiatives across the Emergent network.
This role will serve as the representative of Global Quality on complex technological implementations and ensure the quality and compliance profile of Emergent’s IT portfolio.
The incumbent will advise and guide project teams on questions around Computer System Validation, Electronic Records and Signatures Compliance, and Data Integrity controls and participate in continuous improvement initiatives.
This role is expected to be a liaison with counterparts at both the global and site levels.
This role reports to the Sr, Director Global Quality IT and will work closely with IT, Quality, business functions and sites.
Given the cross functional nature of this role, collaboration, critical thinking, solution orientation, and ability to continually learn are required as is the ability to demonstrate Emergent’s core values and leadership competencies.
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ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions Execute Global QA commitments on strategic QA IT initiatives Ensure compliance with Global Quality Framework on key IT projects and advise teams on potential risks Partner with Computer System Validation in an independent Quality role ensuring validation requirements are adequately met Advise teams on Electronic Records, Electronic Signatures compliance and Data Integrity expectations Partner with cross functional teams on delivering GxP compliant technology solutions to enable Emergent’s business Manage multiple projects demonstrating prioritizing based on risk Coach/advise project team members on quality best practices and industry standards Participate in continuous improvement and innovation initiatives as assigned The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.
Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
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MINIMUM EDUCATION, EXPERIENCE, SKILLS Bachelor’s degree from accredited college or university is required specializing in computer science, information systems, or a related field; advanced degree strongly recommended.
Project management experience 5-8 years of significant experience in the pharmaceutical industry, preferably with track record in project management, quality, and compliance.
Demonstrable experience with Enterprise systems quality and compliance Sound understanding of risk management including identifying, assessing, mitigating and monitoring risks to IT systems and infrastructure Excellent leadership, interpersonal, communication, and problem-solving skills Sound understanding of regulated activities, health authority expectations, and GxP.
Demonstrated leadership in implementing robust quality systems and setting global quality controls in a regulated area.
Experienced in Computerized System Validation Proven experience in the application of Quality Assurance/Compliance, 21 CFR Part 11, DI and other FDA regulations