Quality Assurance Compliance Specialist

Kelly Science & Clinical is seeking a Senior Quality Assurance Coordinator near Cincinnati, OH.

Role Purpose

The Senior Quality Assurance Coordinator plays a strategic and transformative role in modernizing and strengthening the Quality Management System (QMS) and compliance framework across food, cosmetic, pharmaceutical, and specialty chemical operations. This position oversees quality activities spanning four production units, including two major manufacturing sites in the Cincinnati region. Operating with a high degree of autonomy, the Senior QA Coordinator is instrumental in shaping quality systems to drive operational excellence, customer confidence, and scalable growth.

More than day-to-day compliance, this role leads enterprise-level QMS development, governance, and continuous improvement, and is pivotal in evaluating, selecting, and implementing next-generation Quality software to replace existing platforms. This position serves as the primary liaison between Quality, Operations, IT, Regulatory, and external partners to ensure scalable, future-ready quality systems.

Key Responsibilities

QMS Leadership & System Transformation

• 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.

IQS Replacement & Digital Quality Enablement

• 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.

Audit Leadership & Compliance Execution

• 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.

Enterprise Quality Partnership

• 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.

Project Leadership & Continuous Improvement

• 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.

Key Requirements

Education

• Bachelor’s degree in Quality, Science, Engineering, or related field required.
• Advanced degree or relevant certifications strongly preferred.

Experience

• 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.

Certifications

• Certified Quality Auditor (e.g., ASQ, ISO, GFSI, GMP or equivalent) required.
• Internal Auditor certification (ISO 19011) preferred.
• Proven ability to perform and document a range of audits (internal, external, supplier, and regulatory).

Technical & Systems Expertise

• 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.

Leadership & Execution Capability

• Proven experience managing cross-functional projects.
• Strong technical writing and communication skills.
• Ability to work independently with high accountability and authority.
• Experienced in presenting to large groups and facilitating senior-level quality discussions.

Travel

• Willingness and ability to travel up to 20% to support multi-site operations and audits.