What are the responsibilities and job description for the Director, Site Operations position at Piper Companies?
Piper Companies is looking for a Director, Site Operations to join a biotechnology company located in Christiansburg, VA.
Responsibilities of the Director, DPF Site Operations include:
Keywords: GMP, cGMP, GxP, Quality Systems, Quality Compliance, Biologics Manufacturing, Pharmaceutical Manufacturing, Biotech Operations, Designated Pathogen Free (DPF), Animal Facility Operations, Vivarium Management, Barrier Facility, Biosecurity, Xenotransplantation, Organ Transplantation, Porcine Models, Swine Husbandry, IACUC, Institutional Animal Care and Use Committee, FDA Inspections, Regulatory Compliance, Regulatory Submissions, Inspection Readiness, Validation, Process Validation, Equipment Validation, Change Control, Deviations, CAPA, Quality Events, Site Operations Leadership, Facility Operations, Plant Operations, Environmental Monitoring, Sterile Operations, Aseptic Techniques, Materials Management, Resource Planning, Budget Management, Facilities Maintenance, Preventive Maintenance, SOP Development, SOP Compliance, Risk Management, Safety Programs, Biosafety, Continuous Improvement, Operational Excellence, Cross‑Functional Leadership, GMP Documentation, Animal Welfare Compliance, GMP Production Facility, Biological Safety, Contamination Control, Supply Chain in GMP Environments, Technical Operations
Responsibilities of the Director, DPF Site Operations include:
- Overseeing all designated pathogen free (DPF) site operations to ensure compliance with regulatory and quality standards
- Leading site planning, goal setting, and execution in alignment with company milestones
- Managing cross‑functional collaboration across Quality, Animal Care, Facilities Maintenance, and Materials Management
- Reviewing and approving GMP documents, validation materials, quality events, change controls, and deviations
- Directing site budget planning, resource allocation, and vendor/partner relationships
- Chairing IACUC meetings and ensuring adherence to ethical and regulatory requirements in animal care and use
- Leading site safety initiatives and maintaining inspection readiness for regulatory authorities
- Guiding, coaching, and developing direct reports, including performance management and hiring support
- Driving a culture focused on collaboration, compliance, continuous improvement, and right‑the‑first‑time execution
- Bachelor’s degree in life science, engineering, or related field with 15 years of biologics or pharmaceutical experience; or a Master’s degree with 13 years
- Minimum of 8 years of people management experience
- Proven leadership experience in a GMP pharmaceutical or biotech production facility
- Experience interacting with the FDA and, when applicable, ex‑US regulatory agencies
- Strong understanding of cGMP and Quality principles
- Preferred experience with xenotransplantation or organ transplantation
- Rate Range: $175,000–$200,000 base salary, plus 25% annual performance bonus
- Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as required by law
Keywords: GMP, cGMP, GxP, Quality Systems, Quality Compliance, Biologics Manufacturing, Pharmaceutical Manufacturing, Biotech Operations, Designated Pathogen Free (DPF), Animal Facility Operations, Vivarium Management, Barrier Facility, Biosecurity, Xenotransplantation, Organ Transplantation, Porcine Models, Swine Husbandry, IACUC, Institutional Animal Care and Use Committee, FDA Inspections, Regulatory Compliance, Regulatory Submissions, Inspection Readiness, Validation, Process Validation, Equipment Validation, Change Control, Deviations, CAPA, Quality Events, Site Operations Leadership, Facility Operations, Plant Operations, Environmental Monitoring, Sterile Operations, Aseptic Techniques, Materials Management, Resource Planning, Budget Management, Facilities Maintenance, Preventive Maintenance, SOP Development, SOP Compliance, Risk Management, Safety Programs, Biosafety, Continuous Improvement, Operational Excellence, Cross‑Functional Leadership, GMP Documentation, Animal Welfare Compliance, GMP Production Facility, Biological Safety, Contamination Control, Supply Chain in GMP Environments, Technical Operations
Salary : $175,000 - $200,000