Director, QA Compliance

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
• 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!