Clinical Quality Assurance Specialist

Who we are:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline.

Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities.

Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patients!

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Clinical Quality Assurance Specialist to provide oversight and support of various clinical trials, ensuring robust compliance across all applicable regulations.

Specific responsibilities include but are not limited to:

• Develop and maintain robust quality systems

• Establish and maintain effective strategies, systems and procedures, ensuring compliance with applicable GCP standards

• Ensure that all processes contributing to the performance of a clinical trial are conducted properly

• Author/review summary reports, memos and standard operating procedures

• Support internal and regulatory inspections

• Support audited groups in developing effective, risk based corrective actions

• Coordinate, conduct, and/or oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures

• Assist in remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance

• Partner with key customer groups in clinical Operations to develop and meet quality objectives

• Evaluate and improve existing processes with limited guidance

• Maintain on the job knowledge and skills by participating in applicable training

• Other duties as assigned

Experience and Skills Desired:

• BS/BA in Life Sciences or related field

• 5+ years' relevant experience in healthcare, biotech or pharmaceutical industry

• Qualified auditor experience is highly preferred

• Working knowledge of GCP regulations/ guidelines (ICH, US FDA, ISO)

• Clinical Research Certification, desired

• Strong computer skills

• Excellent communication (verbal and written) skills and ability to work effectively on teams

• Excellent organizational skills

• Ability to travel

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.