Director, DPF Site Operations
United Therapeutics Corporation
4 hours ago
On-site
Christiansburg, VA
Operations
Responsibilities:
- Direct and oversee all designated pathogen free (DPF) site operations, ensuring adherence to regulatory requirements and quality standards
- Plan, direct, and set departmental/function goals aligned with company milestones and support overall strategy
- Organize and lead projects driving quality and compliance at the site
- Establish site policies/practices/programs and review/approve site validation documents for compliance and accuracy
- Manage site budget and expenses; 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 GMP and regulatory compliance
- Cultivate and maintain external relationships with third-party suppliers/partners, key customers, and professional organizations
- Lead cross-functional team collaboration to achieve project milestones on target
- Foster a culture of collaboration, quality, compliance, right-the-first-time execution, and continuous improvement
- Collaborate with other DPF sites for a unified operational approach
- Interact with regulatory authorities during facility inspections
- Direct and manage direct reports (training, goal setting, performance management, coaching/mentoring, career development, and support recruitment as needed)
Minimum Requirements:
- Bachelor’s degree in life science, engineering, or related field + 15+ years of biologics or pharmaceutical experience
OR Master’s degree + 13+ years of biologics or pharmaceutical experience
- 8+ years of people management experience
- Experience leading teams in a GMP pharmaceutical/biotech production facility
- Experience interfacing with the U.S. FDA and, as appropriate, ex/US regulatory agencies
- Strong knowledge of cGMP compliance and Quality
Preferred Qualifications:
- Master’s degree in life science, engineering, or related field
- Experience and understanding of xenotransplantation and/or organ transplantation
Job Location & Travel:
- Fully onsite at Christiansburg, VA; travel up to 10%
- Direct and oversee all designated pathogen free (DPF) site operations, ensuring adherence to regulatory requirements and quality standards
- Plan, direct, and set departmental/function goals aligned with company milestones and support overall strategy
- Organize and lead projects driving quality and compliance at the site
- Establish site policies/practices/programs and review/approve site validation documents for compliance and accuracy
- Manage site budget and expenses; 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 GMP and regulatory compliance
- Cultivate and maintain external relationships with third-party suppliers/partners, key customers, and professional organizations
- Lead cross-functional team collaboration to achieve project milestones on target
- Foster a culture of collaboration, quality, compliance, right-the-first-time execution, and continuous improvement
- Collaborate with other DPF sites for a unified operational approach
- Interact with regulatory authorities during facility inspections
- Direct and manage direct reports (training, goal setting, performance management, coaching/mentoring, career development, and support recruitment as needed)
Minimum Requirements:
- Bachelor’s degree in life science, engineering, or related field + 15+ years of biologics or pharmaceutical experience
OR Master’s degree + 13+ years of biologics or pharmaceutical experience
- 8+ years of people management experience
- Experience leading teams in a GMP pharmaceutical/biotech production facility
- Experience interfacing with the U.S. FDA and, as appropriate, ex/US regulatory agencies
- Strong knowledge of cGMP compliance and Quality
Preferred Qualifications:
- Master’s degree in life science, engineering, or related field
- Experience and understanding of xenotransplantation and/or organ transplantation
Job Location & Travel:
- Fully onsite at Christiansburg, VA; travel up to 10%