Quality Control Supervisor

Our client is a growing clinical research organization focused on delivering high-quality clinical trial execution, helping sponsors bring new therapies to market safely and efficiently. The organization operates multiple sites and continues to expand its portfolio of specialized studies across the U.S.

Job Description

The Quality Control (QC) Supervisor oversees day-to-day QC for study protocols at the site, ensuring activities are performed consistently and in compliance with FDA regulations, ICH GCP guidelines, and company policies. The role develops and maintains QC plans and workflows, supports QC execution in real time and through ongoing review, and tracks study trends, queries, and risks to help ensure accurate, timely deliverables.

Reporting to the Director of Quality Assurance and Compliance, the QC Supervisor oversees QC Specialists and supports eQMS maintenance, CAPA activities, QC-related SOPs and work instructions, and reporting metrics used to evaluate study and site risk. The role also helps train staff on key QC concepts and works closely with quality and operational leadership to assess risk, support sponsor commitments, and align QC activities with site goals.

Responsibilities

Team Leadership and Training

• Directs QC Specialists and clinical staff (where required), coordinating daily workloads, assessing and ensuring competency of staff executing QC of data, monitoring trends and communicating those to Operational Leadership for management and support
• Oversees and escalates any vendor quality concerns to the Director of Quality and Compliance and Operational Leadership for visibility and vendor management if identified
• Ensures technology is leveraged and applicable regulations that support technology and security are implemented and compliance maintained

Data Analysis and Troubleshooting

• Performs QC reviews of essential trial documents and electronic systems that house trial documents or data as applicable
• Verifies that site SOPs/WIs are being complied with when conducting QC (via documentation and/or observation)
• Reviews data QC'd by other team members to ensure consistency and compliance, trend analysis, escalation to Quality Event or CAPA management, and supports immediate containment efforts such as contemporaneous corrections or immediate corrective actions to mitigate risks quickly
• Utilizes a global approach to managing risk and containment efforts when the same clinical trials are conducted at other portfolio sites
• May conduct site-level internal audits and data checks at specific or ad hoc frequencies as determined by the Director of Quality and Compliance

Audit and Inspection Readiness

• Supports the Director of Quality and Compliance with audit and inspection needs as directed
• Ensures QC deliverables required per SOPs/WIs are being managed in a compliant fashion and are audit ready
• Supports management of any audit findings to completion and supports effectiveness checks as needed and directed by the Director of Quality and Compliance

This position may evolve to reflect the company's strategic growth objectives and early-phase development focus. This job description outlines the general scope and level of responsibility and is not intended to be an exhaustive list of duties.

Skills and Qualifications

Education and Experience

• Bachelor's degree in a related field and a minimum of 5 years of clinical research experience with a preferred background inclusive of quality assurance/quality control
• Must have a deep understanding of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods
• Bilingual in Spanish and English (essential) 
• Phase I clinical research experience preferred

Skills & Competencies

• Understands and can train staff on regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines
• Sound and in-depth understanding of protocols, protocol dissection, and the full lifecycle of a clinical trial
• Knowledgeable in medical terminology
• Excellent communication skills (interpersonal, written, verbal)
• Solid computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry such as Clinical Trial Management Systems (CTMS)
• Ability to be a leader and strong team-building support initiative
• Strong organizational, problem-solving, and cross-functional communication skills