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Senior, niche ETQ/QMS skillset and regulated experience reduce applicant density despite metro location.
Strong regulatory and QMS domain requirements make cross-industry transferability limited and specialized.
Explicit 8+ years, mandatory ETQ/QMS experience and regulated validation requirements create strict shortlisting filters.
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Design and implement enterprise quality management system (QMS) technical solutions, overseeing all technical delivery and supporting system owners.
Define and enforce IT application standards aligned with global IT and industry best practices, manage platform roadmaps, and ensure timely IT security vulnerability resolution.
Lead technical transformation by advocating system improvements, minimizing customization, managing support levels (L2 to global team, retain L3 and change management), and partnering with business leaders for needs assessment.
Bachelor’s degree required.
8+ years of hands-on experience designing, configuring, implementing, and maintaining enterprise quality management systems, preferably with ETQ, IQVIA, and Force.com platforms.
Experience with regulated environments or understanding of pharmaceutical/medical device regulatory compliance preferred but not explicitly mandatory.
Work Experience Required: 8+ years in relevant QMS roles.
Strong experience with ETQ and similar QMS platforms and enterprise application architectures, including integration via APIs and server administration.
Familiarity with regulated environments, 21 CFR part 820 compliance, and SDLC validation deliverables (IQ/OQ/SDD) execution in validated applications.
Ability to operate in global matrixed IT environments, manage vendor relations, and communicate effectively with senior leadership on technical matters.