Melissa Schulz
@melissaschulz
Quality & compliance operations leader improving regulated reliability and audit readiness.
United StatesWhat I'm looking for
I’m a results-driven Quality and Compliance Operations leader with 15+ years of experience in healthcare IT, pharmaceutical, and other regulated environments. I’ve led QA programs, incident management, and process improvement initiatives for organizations including Pfizer and United BioSource.
In recent roles, I’ve built structured incident response workflows and automated escalation protocols in ServiceNow and Power Automate—cutting MTTR by 25%. I also chaired the Change Control Board (CAB) to ensure zero unauthorized high-risk changes reached production, and I used KPI dashboards to improve technical issue resolution timelines by 20%.
I’m equally strong in governance and quality systems: I established SOP lifecycle governance to reduce overdue policy reviews by 30%, and led cross-functional Root Cause Analysis (RCA) and CAPA processes to cut repeat incidents by 45%. With experience across GCP/cGMP, QMS/eQMS, and ISO-aligned auditing (including ISO 13485 and ISO 19011), I bring a practical, audit-ready mindset to continuous compliance and operational excellence.
Experience
Work history, roles, and key accomplishments
Independent Consultant
Self-Employed
Jan 2025 - Present (1 year 5 months)
Manage e-commerce and digital marketing operations including product listings, content workflows, Amazon affiliate programs, and print-on-demand fulfillment across Etsy and Printify. Apply QA and process-management practices to build scalable SOPs, content trackers, and operational workflows using tools such as Canva, Pinterest, and Amazon Associates.
Reliability & Quality Manager
United BioSource, LLC
Jan 2022 - Jan 2025 (3 years)
Led reliability, quality, and incident operations for critical healthcare IT systems, reducing MTTR by 25% by designing incident response workflows and automated escalation via ServiceNow/Power Automate. Improved production governance with CAB oversight (zero unauthorized high-risk changes), accelerated resolution timelines by 20% using KPI dashboards, and reduced repeat incidents by 45% through R
Document Control Specialist
C2N Diagnostics
Jan 2021 - Jan 2022 (1 year)
Architected eDMS governance protocols in MasterControl and Veeva to improve audit readiness and document traceability for regulated submissions. Managed Trial Master File (TMF) inspection readiness and led automation transitions to enhance metadata control and scalable user access management.
Oversaw clinical trial activities in alignment with GCP/cGMP and global regulatory standards, supporting mission-critical healthcare products. Managed CAPA and deviation programs using risk-based oversight, partnered with DevSecOps and engineering to streamline software-driven compliance, and analyzed cross-functional data to identify systemic risks and drive continuous improvement.
Led full QA operations in a cGMP-regulated plasma environment, maintaining inspection readiness through major regulatory audits. Used center KPIs to identify operational risks and implemented measurable process improvements while delivering training on QA policies, regulatory compliance, and SOP adherence.
Education
Degrees, certifications, and relevant coursework
Anthem College
Associate of Science
Earned an Associate of Science at Anthem College in Fenton, Missouri.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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