Kelly Science, Engineering, Technology & Telecom · 9 hours ago
Quality Assurance Compliance Specialist
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
3+ years expKelly Science & Clinical is seeking a Senior Quality Assurance Coordinator to modernize and strengthen the Quality Management System (QMS) across various operations. This role oversees quality activities, leads enterprise-level QMS development, and serves as a liaison between multiple departments to ensure effective quality systems.
Staffing & Recruiting
Hiring Manager
Cristina Weed, MBA
Responsibilities
Serve as enterprise quality lead for design, implementation, governance, and continuous improvement of the global QMS
Own the QMS transformation roadmap, including documentation architecture, workflow design, system integration, performance metrics, and governance standards
Act as business owner for the future-state QMS ecosystem, encompassing digital quality platforms and data governance
Lead strategy and project implementation for the next-generation QMS platform
Collaborate with IT, Operations, Regulatory, and external vendors to define requirements, manage migration, drive user adoption, and ensure sustainable change management
Ensure that new systems strengthen audit readiness, traceability, CAPA, complaints management, document control, and regulatory reporting
Lead the execution and reporting of external audits (customer, regulatory, certification, supplier)
Plan and conduct supplier and service audits, producing formal reports and managing corrective action follow-up
Serve as a senior technical authority on GMP, ISO, GFSI, FDA, and customer compliance requirements
Serve as a strategic quality partner to Operations, Supply Chain, Commercial, R&D, and Corporate functions across multiple production units
Provide executive-level insight on compliance risks, emerging trends, and quality performance
Design and deliver quality training programs and present complex quality topics to large groups
Lead complex, cross-functional quality projects using established project management methodologies
Drive Kaizen, root cause investigations, and continuous improvement initiatives throughout the manufacturing network
Establish and maintain enterprise KPIs and dashboards for monitoring QMS performance and compliance health
Qualification
Required
Bachelor's degree in Quality, Science, Engineering, or related field required
Minimum 3–5 years of progressive experience in a GMP manufacturing and/or laboratory environment
Demonstrated success in leading QMS programs, audits, and system transformation projects
Certified Quality Auditor (e.g., ASQ, ISO, GFSI, GMP or equivalent) required
Advanced experience with QMS/LMS platforms
Expertise in leading digital quality system implementations and enterprise platform design
Strong knowledge of ERP systems, SharePoint, and document control infrastructures
Proven experience managing cross-functional projects
Strong technical writing and communication skills
Ability to work independently with high accountability and authority
Willingness and ability to travel up to 20% to support multi-site operations and audits
Preferred
Advanced degree or relevant certifications strongly preferred
Internal Auditor certification (ISO 19011) preferred
Proven ability to perform and document a range of audits (internal, external, supplier, and regulatory)
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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