Job ID: JOB_ID_2157
Role Summary
The Senior IT Quality Control Specialist is a pivotal leadership role within the clinical research and healthcare technology sector. This position is primarily responsible for the oversight of software validation, data integrity, and comprehensive quality assurance processes within a strictly regulated clinical research environment. As a senior professional, you will ensure that all IT systems and validation activities remain in full compliance with FDA regulations, GxP requirements, 21 CFR Part 11, and other pertinent global regulatory standards. This position is 100% remote and requires a high degree of self-management and technical expertise in regulatory compliance.
Key Responsibilities
- Provide expert guidance to IT and research operations teams regarding regulatory requirements for software validation and GxP.
- Review and approve validation lifecycle documentation, including validation assessments and 21 CFR Part 11 compliance reports.
- Oversee the preparation and execution of IQ, OQ, and PQ protocols, ensuring data analysis and reporting meet industry standards.
- Manage change control documentation for validated systems to maintain a state of compliance.
- Conduct periodic reviews of system documentation to ensure ongoing adherence to regulatory expectations.
- Support and host sponsor audits and regulatory inspections, providing necessary documentation and follow-up.
- Develop and refine IT standards, policies, and procedures within the Quality Management System (QMS).
- Stay abreast of evolving FDA regulations and assess their impact on internal validation processes.
- Mentor junior staff on quality improvement practices and QMS processes.
Required Qualifications
- Bachelor’s degree in a relevant field (or equivalent professional experience).
- Minimum of 5-10 years of experience in IT validation and quality control within a regulated environment (Pharma, Biotech, or CRO).
- Deep understanding of FDA GxP, 21 CFR Part 11, and software validation guidelines.
- Experience with risk management and change control processes.
- Strong technical writing skills and the ability to interpret complex regulatory guidance.
- Excellent communication skills for cross-functional collaboration with IT and business stakeholders.
Preferred Skills
- Knowledge of EU Annex 11 and GAMP V standards.
- Awareness of PIC/S and ICH standards for global clinical trials.
- Experience with automated testing tools in a validated environment.
Special Requirements
PV W2, LinkedIn required, Assessment test required, Skype interview, 100% remote
Compensation & Location
Salary: $135,000 – $175,000 per year (Estimated)
Location: Remote
Recruiter / Company – Contact Information
Recruiter / Employer: HCA Healthcare Corporation
Email: pbaghel@vyzeinc.com
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