Technical Quality Systems Consultant
CornerStone Technology Talent Services
IT, Quality Assurance
Lewisville, TX, USA
Posted on Jun 12, 2025
Web Job Title:
Technical Quality Systems Consultant Regulatory, Validation & Compliance Expert (Pharma/OTC, Onsite Lewisville, TX)
Position Summary:
CornerStone Technology Talent Services partners with market leaders in life sciences, pharmaceuticals, and health & beauty to deliver expert technical talent that drives compliance, quality, and innovation. We are seeking a Technical Quality Systems Consultant to support a leading OTC drug and personal care manufacturing operation in Lewisville, TX.
This contract-to-hire opportunity offers the chance to lead critical quality assurance initiatives that ensure FDA and global regulatory compliance, support computer systems and process validation efforts, and strengthen site inspection readiness. The role combines technical depth with cross-functional influence, contributing to operational excellence and long-term regulatory strategy.
Position Focus:
The consultant will serve as a key member of the Quality Systems team, executing deep-dive root cause investigations, driving continuous improvement in quality and validation practices, and ensuring readiness for FDA and other regulatory body inspections. The role requires hands-on expertise in computer systems validation, strong command of OTC regulatory standards, and proven success navigating complex regulated environments.
Key Responsibilities:
Conduct investigations and apply root cause analysis methodologies for quality and compliance events
Lead internal audits and support site readiness for FDA and global health authority inspections
Drive computer systems validation (CSV) and support validation activities for process, equipment, and stability programs
Support document control processes including batch record review, annual product reviews, and quality metrics reporting
Analyze quality trends, implement corrective and preventive actions (CAPA), and monitor the effectiveness of quality initiatives
Collaborate with cross-functional teams including R&D, Manufacturing, Legal, and Compliance to drive proactive quality culture and continuous improvement
Contribute to validation and regulatory strategy aligned with long-term business goals and evolving regulatory expectations
Required Experience and Competencies:
Proven expertise in quality investigations, root cause analysis, and CAPA management
Demonstrated experience in computer systems validation (CSV), aligned with FDA and global expectations
Strong working knowledge of OTC drug manufacturing regulations, FDA compliance frameworks, and cGMP standards
Experience preparing for and supporting successful FDA and global regulatory inspections
Exceptional communication and collaboration skills;ability to influence across functional areas
Bachelor s degree in Chemistry, Microbiology, or a related technical discipline
Minimum of 3 years of hands-on experience in Quality Assurance or Quality Control in regulated pharmaceutical, life sciences, or cosmetics manufacturing
Preferred Credentials:
Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Quality Manager (CQM) credentials preferred
Position Details:
Location: Onsite in Lewisville, TX (remote work is not available for this role)
Schedule: Monday through Friday;8 AM 4 PM or 9 AM 6 PM
Engagement: Contract-to-Hire with long-term opportunity for the right candidate
Why CornerStone TTS:
CornerStone Technology Talent Services delivers skilled technical talent where it matters most in regulated environments where precision, compliance, and innovation intersect. We understand the demands of life sciences and OTC manufacturing and bring candidates into roles where they can drive measurable impact. Our commitment is to the success of our clients, candidates, and the communities they serve.
If you are ready to elevate your career in quality systems and regulatory strategy, we look forward to connecting with you.