Director, DPF Site Operations

Role Summary

Director, DPF Site Operations will manage day-to-day operations for the designated pathogen-free (DPF) site at Christiansburg, VA, ensuring production of high-quality organs for GMP use, including human transplantation. This hands-on leader will drive regulatory compliance, risk management, and operational efficiency, collaborating with Quality, Animal Care, Facilities Maintenance, and Materials Management to meet project goals and uphold high standards. This role requires onsite work in Christiansburg, VA with up to 10% travel.

Responsibilities

• Direct and oversee all DPF site operations, ensuring adherence to regulatory requirements and quality standards
• Responsible for planning, direction and goal setting for the department/function in alignment with company milestones, and support the function's overall strategy
• Organize and lead projects that drive quality and compliance at the site
• Establish necessary policies, practices and programs for site, and review and approve site validation documents for compliance and accuracy
• Manage site budget and expenses and ensure efficient resource allocation
• Chair site Institutional Animal Care and Use Committee (IACUC) meetings to ensure ethical and regulatory compliance in animal care and use
• Author, review, and approve quality events, including change controls and deviations
• Lead safety initiatives at the site to maintain a secure and compliant working environment
• Collaborate with Quality and Regulatory teams to ensure continuous compliance with GMP and other regulatory standards
• Cultivate and maintain external relationships with third-party suppliers and partners, key customers, and professional organizations
• Lead and ensure collaboration of a cross-functional team to ensure project milestones are achieved on target
• Foster a culture of collaboration, quality, compliance, right-the-first-time execution, and continuous improvement at the site
• Collaborate with other DPF sites to help ensure a unified operational approach across sites
• Interact with regulatory authorities during facility inspections
• Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)

Qualifications

• Required: Bachelor’s degree in life science, engineering, or related field; 15+ years of biologics or pharmaceutical experience
• Required: Master’s degree in life science, engineering, or related field; 13+ years of biologics or pharmaceutical experience
• Required: 8+ years of people management experience
• Required: Experience leading teams in a GMP pharmaceutical or biotech production facility
• Required: Experience interfacing with the U.S. Food and Drug Administration (FDA) and/or other regulatory agencies
• Required: Strong knowledge of cGMP compliance and quality
• Preferred: Master’s degree in life science, engineering, or related field
• Preferred: Experience and understanding of Xenotransplantation and/or organ transplantation