Overview
Director, QA Compliance Jobs in United States at CSG Talent
Title: Director, QA Compliance
Company: CSG Talent
Location: United States
Are you a seasoned quality leader with a passion for ensuring excellence in GxP compliance? A leading biotech company is seeking a Director, QA Compliance to drive the development and oversight of its Quality Management System (QMS) and ensure compliance with GMP, GCP, and GLP regulations across global operations. This is a high-impact role with the opportunity to influence quality strategy and support innovative therapies from clinical development to commercialization.
Key Responsibilities:
Lead the development, implementation, and governance of the company’s QMS
Oversee GxP compliance programs, including deviations, CAPAs, audits, vendor oversight, and regulatory inspections
Drive risk management initiatives, ensuring proactive identification and mitigation of compliance risks
Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle
Provide strategic guidance on regulatory requirements, industry trends, and continuous improvement initiatives
Act as a key liaison during regulatory inspections and external audits
What We’re Looking For:
Six or more years of experience in QA compliance within biotech, biopharma, CRO, or CDMO environments
Experience working in an environment between early clinical through commercial drug product development lifecycle
Demonstrated success in design, implementation and management of modern quality systems (QMS)
Strong knowledge of FDA, ICH, and global GxP regulations and industry best practices
Expertise in quality systems management, risk assessment, and audit processes
Proven leadership experience, with the ability to influence and drive a culture of quality
Excellent problem-solving, communication, and cross-functional collaboration skills
Experience supporting regulatory submissions and interactions is a plus
Why Join Us?
Be part of a dynamic team focused on developing groundbreaking therapies
Work in an environment that values innovation, quality, and continuous improvement
Hybrid or remote work options available, with approximately 20% travel
If you’re ready to take the next step in your QA career and make a meaningful impact in biotech, apply today!
