QA Director
Job Title: QA Director
Location: Virginia, USA (Local candidates only)
Work Arrangement: 100% Onsite
Job Description
Our client is seeking an experienced QA Director to lead and oversee Quality Assurance activities at their Virginia-based site. This role provides both strategic and operational leadership for the Quality function, ensuring robust quality systems, sustained GMP compliance, and alignment with regulatory expectations. The QA Director will play a critical role in supporting manufacturing and innovative operations while fostering a strong culture of quality across the organization.
This position operates within a highly regulated, GMP-driven environment that is not a traditional medical device or small-molecule pharmaceutical organization. The division is advancing groundbreaking and life-saving technologies in xenotransplantation and organ engineering, requiring strong quality leadership, adaptability, and sound regulatory judgment.
Key Responsibilities
- Provide strategic leadership and oversight of all Quality Assurance functions at the site.
- Ensure the design, implementation, and continuous improvement of robust Quality Management Systems (QMS).
- Maintain full compliance with GMP regulations, internal standards, and applicable regulatory requirements.
- Lead, mentor, and develop QA teams, promoting accountability and a culture of quality excellence.
- Support manufacturing, operational, and technical activities with strong quality oversight and risk-based decision-making.
- Partner cross-functionally with Manufacturing, Technical Operations, Regulatory, and R&D teams.
- Support quality oversight for innovative technologies and non-traditional manufacturing models.
- Prepare the site for regulatory inspections and audits, serving as a key quality representative.
Key Qualifications
- Extensive experience in Quality Assurance within GMP-regulated environments.
- Proven leadership experience in a Director-level or senior QA management role.
- Strong working knowledge of Quality Management Systems, regulatory compliance, and inspection readiness.
- Demonstrated ability to lead teams, influence stakeholders, and drive cross-functional collaboration.
- Experience within highly innovative or non-traditional regulated environments preferred.
- Background or exposure to xenotransplantation, advanced biotechnologies, or emerging therapeutic platforms is highly desired.
Technology & Scientific Focus Areas
The work supported by this role spans three major technological pillars:
- Xenotransplantation: Transplantation of genetically modified animal organs (primarily porcine) into human patients to prevent immune rejection.
- Organ Humanization: Removal of animal cells from organs to create a biological scaffold, which is later repopulated with human cells.
- 3D Bioprinting: Bioprinting of organs followed by humanization for transplant and therapeutic use.
Summary
This is a contract opportunity with ProQuality Network, supporting operations at our client’s site in Virginia. Candidates must be local and available to work 100% onsite. This role offers a unique opportunity to lead Quality Assurance within a highly regulated, innovative environment focused on transformative technologies with the potential to save human lives.
Qualified candidates with strong QA leadership experience and an interest in cutting-edge biotechnology are encouraged to apply inside the job description link with an updated resume.