Clinical Quality Assurance Specialist
Krystal Biotech
Summary
Krystal Biotech, Inc is seeking a highly motivated Clinical Quality Assurance and Trial Master File (TMF) Specialist to support the management of essential clinical trial documents and clinical quality systems.
Job description
Job Description Summary
Krystal Biotech, Inc is seeking a highly motivated Clinical Quality Assurance and Trial Master File (TMF) Specialist to support the management of essential clinical trial documents and clinical quality systems.
Primary Responsibilities
- Receive, organize, and manage essential clinical trial documents to ensure compliance with regulations and internal SOPs/plans.
- Review and upload trial documents to electronic TMF system and track document status.
- Assist in conducting quality checks on trial artifacts for completeness, accuracy, and timeliness.
- Support study teams to resolve essential document discrepancies.
- Collaborate with study staff and TMF managers to ensure the TMF is inspection-ready.
- Assist in the development and maintenance of clinical quality systems.
- Support internal and regulatory inspections.
- Conduct GCP audits (e.g., vendor, study, and internal process audits) to ensure compliance with applicable GCP/regulatory requirements and policies/procedures.
- Assist in the development of corrective and preventive action plans and in the assessment of their effectiveness.
- Participate in risk assessment of clinical trial protocols.
- Other duties as assigned.
Requirements and Preferred Qualifications
- BS/BA in Life Sciences or related field.
- 2+ years' relevant experience in healthcare, biotech or pharmaceutical industry.
- Knowledge of GCP guidelines, FDA regulations, and TMF reference model.
- Proficiency with electronic TMF platforms (Veeva Vault), desired.
- Strong knowledge of clinical study documents.
- Excellent organizational skills.
Requirements
- BS/BA in Life Sciences or related field
- 2+ years' relevant experience in healthcare, biotech or pharmaceutical industry
- Knowledge of GCP guidelines, FDA regulations, and TMF reference model
- Proficiency with electronic TMF platforms (Veeva Vault), desired
- Strong knowledge of clinical study documents
- Excellent organizational skills
Company overview
Krystal Biotech, Inc. is a commercial-stage biotechnology company founded in 2016 and headquartered in Pittsburgh, Pennsylvania. The company specializes in the discovery, development, and commercialization of genetic medicines for diseases with high unmet medical needs. Krystal Biotech achieved a significant milestone in May 2023 when it received FDA approval for VYJUVEK®, the first-ever redosable gene therapy and the only medicine approved for treating dystrophic epidermolysis bullosa (DEB). This groundbreaking topical gene therapy gel delivers two copies of the COL7A1 gene directly to DEB wounds, addressing the fundamental disease-causing mechanism at the molecular level. The company leverages its proprietary herpes simplex virus type 1 (HSV-1) gene delivery platform to develop a robust pipeline of investigational genetic medicines across multiple therapeutic areas including respiratory diseases, oncology, dermatology, ophthalmology, and aesthetics. With state-of-the-art GMP manufacturing facilities in Pittsburgh and global operations extending to Switzerland, Germany, and Japan, Krystal Biotech has established itself as a global leader in redosable gene therapy technology, pioneering innovative approaches to treat rare genetic disorders.