Job Details

West Leland Group is supporting a commercial-stage pharmaceutical company strengthening its Quality Management System and compliance infrastructure. We are seeking a Senior Director, Quality Systems who will manage quality system functions covering manufacturing, packaging, laboratory, warehouse, IT, and external partner operations. This leader will maintain a strong state of compliance with applicable regulations while shaping systems, processes, and personnel supporting inspection readiness and continuous improvement.

Location: On-Site (Greenville, SC)

What You'll Do

• Lead the development, implementation, and maintenance of the company's GxP Quality Management System to ensure compliance with regulatory requirements.
• Direct Document Control, External Quality, and Quality Systems teams, including responsibility for staffing, performance coaching, training, and professional development.
• Establish effective quality processes and monitor compliance through quality metrics and routine management reviews.
• Provide oversight of product documentation, including batch records, specifications, and finished goods release supporting compliant lifecycle management.
• Make risk-based decisions for deviations, CAPAs, change controls, complaints, and product disposition.
• Maintain a proactive state of inspection readiness through management of the internal audit program and leadership during partner audits and regulatory inspections.
• Ensure appropriate oversight of facilities, utilities, equipment, environmental monitoring, and preventative maintenance activities.
• Lead Quality Council activities, evaluate trends, escalate issues, and recommend continuous improvement opportunities.
• Maintain the risk register and direct prioritization and remediation strategies.
• Ensure document integrity and alignment with ALCOA principles throughout GxP processes.
• Lead cross-functional change governance including review and approval of change requests.
• Oversee supplier quality activities including qualification, Quality Agreements, audits, and follow-up on corrective actions.
• Partner collaboratively across internal functions and external stakeholders to resolve issues and support operational efficiency.

What You Bring

• Bachelor's degree in a scientific or related discipline required; advanced degree preferred.
• 15+ years of pharmaceutical industry experience with increasing levels of responsibility in Quality Assurance.
• 10+ years of leadership experience managing quality system functions.
• Experience across multiple areas of Quality including auditing, investigations, complaints, electronic systems, commercialization, and regulatory inspection support.
• Strong knowledge of FDA regulations and proven success implementing compliant systems in dynamic environments.
• Experience supporting external manufacturing and supplier oversight preferred.
• Excellent communication, conflict management, and decision-making skills.

Why Join

• High-impact leadership role overseeing quality system effectiveness across the business.
• Opportunity to strengthen inspection readiness and compliance strategy.
• Meaningful work supporting patient safety and consistent product quality.

About West Leland Group

West Leland Group is a boutique recruiting firm specializing in Quality, Regulatory, and R&D roles for medical device, biotech, and pharmaceutical companies. With deep industry expertise and a long-term, relationship-driven approach, we help innovative organizations build the teams driving better health outcomes. Thoughtful Search. Purposeful Hiring.

This search is being managed by West Leland Group on behalf of our client. West Leland Group is an equal opportunity search partner. Qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. This is a direct-hire position with a client company offering competitive compensation and benefits.