Ref : GEN26.04.01
Compagny : GENOSKIN INC
Address : 4 technology way, Salem MA 1970
Benefits
20 days PTO
Company-sponsored Healthcare & Dental
401K
Who We Are
Genoskin is a life science company with operations in Toulouse, France, and Salem, MA, dedicated to reducing the risks associated with drug, vaccine, medical device, and cosmetic development through advanced non-clinical testing solutions.
We operate a hybrid business model, combining CRO services with the manufacturing of proprietary human skin models and primary human mast cells. Our bio-stabilized, immunocompetent, and injectable skin platforms, together with our immune cell systems, offer early access to high-quality human data. These technologies serve as reliable, ethical alternatives to animal testing, supporting more predictive and sustainable research and development.
To deliver high-impact results, we integrate our biological platforms with cutting-edge analytical technologies—including next-generation transcriptomics, multiplexed proteomics, flow cytometry, spatial biology, and advanced bioinformatics—to generate actionable insights that accelerate therapeutic development while reducing cost, time, and risk.
Mission
We are seeking a Biospecimen Sourcing & QA Specialist to lead two strategic missions:
- Ensure the ethical sourcing, documentation, and logistics of human skin samples from clinical partners.
- Manage and improve the Quality Management System (QMS) of our U.S. site in compliance with ISO 9001.
This cross-functional role is central to our supply chain and operational compliance, supporting both tissue procurement workflows and quality assurance activities.
Key responsibilities
Human Biological Sample Sourcing – Primary Mission
- Coordinate the ethical sourcing, transport, and traceability of discarded human skin tissues from surgeries (e.g. abdominoplasty, breast reduction).
- Develop and manage partnerships with U.S.-based clinics, hospitals, and tissue providers.
- Ensure compliance with U.S. regulatory and ethical standards (informed consent, HIPAA, IRB).
- Maintain up-to-date inventory tracking, supplier documentation, and traceability records.
- Collaborate with legal and scientific teams to manage provider agreements and ensure audit readiness.
- Forecast sample needs and monitor supply reliability for production and R&D pipelines.
- Seek and propose and qualify alternative sourcing options to maintain robust supply.
Quality Assurance Management
- Lead preparations and follow-ups for ISO 9001 audits and renewals.
- Maintain and improve the Quality Management System based on Genoskin’s operational needs.
- Conduct or coordinate internal quality audits; manage deviations, CAPAs, and SOP reviews.
- Ensure the effective communication and training of QA procedures to staff.
- Organize and lead quality meetings and KPI reporting.
- Onboard and support new staff in using Genoskin’s QMS tools.
- Ensure compliance with GLP principles, documentation standards, and risk management.
Required Qualifications
- Degree in Life Sciences, Quality Management, Biomedical Engineering, or equivalent.
- 1+ years of experience in QA or clinical sourcing in biotech, pharma, or CRO/CDMO environments.
- Solid understanding of ISO 9001, GLP/GMP, and QMS operations.
- Experienced with human tissue sourcing, biobanking, or surgical tissue logistics, IRB.
- Excellent organizational and cross-functional communication skills.
Skills
- Autonomous, structured, and solution-oriented.
- Proven ability to work in regulated environments with high quality expectations.
- Strong ethical mindset regarding human sample usage and donor rights.
- Comfortable navigating across international, multidisciplinary teams.
Contact
Resume and cover letter should be sent through LinkedIN.
