Director, DPF Operations - Christiansburg

United Therapeutics•Christiansburg, VA

8d•Onsite

About The Position

The Director, DPF Operations oversees daily operations at United Therapeutics’ designated pathogen free (DPF) facility in Christiansburg, Virginia. The role brings together Quality, Animal Care, Facilities Maintenance, and Materials Management to align teams, resources, and priorities; achieve project milestones; maintain regulatory compliance and high quality standards; strengthen safety; and improve operational efficiency. The position supports production of high-quality organs for GMP use, including human transplantation. The Director is accountable for site operations, planning and goal setting, quality and compliance projects, site policies and practices, validation documents, budget and resource allocation, safety initiatives, and regulatory interactions. The role leads a cross-functional team and direct reports, develops external relationships, collaborates with other DPF sites, and fosters a culture of collaboration, accountability, continuous improvement, and right-the-first-time execution.

Requirements

Bachelor’s degree in life science, engineering, or another related field and 15 or more years of experience in biologics pharmaceuticals, swine production, or biomedical animal facility operations, with demonstrated responsibility for quality, compliance, and operational performance; or a master’s degree in a related field and 13 or more years of such experience.
At least 8 years of people management experience.
Experience leading teams in a GMP pharmaceutical or biotech production facility, or in swine production or biomedical animal operations with rigorous biosecurity, documented procedures, training, and audit requirements.
Experience supporting inspections or audits and addressing findings in a regulated production or animal-care environment.
Strong knowledge and demonstrated application of quality systems, procedural compliance, controlled documentation, investigation of operational issues, and corrective actions.
Experience leading collaboration across cross-functional teams.
Education, experience, and documented results in leadership and project management.
Experience in problem solving, negotiations, presentations, and collaborative team-building with non-direct reports across multiple geographies and cultures, as well as external parties.
Proficiency with the Microsoft Office software suite.

Nice To Haves

Master’s degree in life science, engineering, or another related field.
Direct FDA or international health-authority inspection experience.
Strong knowledge of cGMP and experience applying pharmaceutical quality systems.
Experience and understanding of xenotransplantation and/or organ transplantation.

Responsibilities

Direct and oversee all DPF site operations, ensuring adherence to regulatory requirements and quality standards.
Plan, direct, and set goals for the department or function in alignment with company milestones and the function’s overall strategy.
Organize and lead projects that drive quality and compliance at the site.
Establish necessary site policies, practices, and programs, and review and approve site validation documents for compliance and accuracy.
Manage the 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 site safety initiatives 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 relationships with third-party suppliers and partners, key customers, and professional organizations.
Lead cross-functional collaboration to ensure project milestones are achieved on target.
Foster a site culture of collaboration, quality, compliance, right-the-first-time execution, and continuous improvement.
Collaborate with other DPF sites to support a unified operational approach.
Interact with regulatory authorities during facility inspections.
Manage direct reports, including training, goal setting and achievement, performance evaluations and management, coaching, mentoring, career development, and recruitment support as needed.
Perform other duties as assigned.