Description

Responsible Pharmacist (Pharmacien Responsible)

About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Role Overview: The Responsible Pharmacist ensures that all pharmaceutical activities comply with French and European regulations.

They are legally accountable to the French Health Authorities (ANSM) for the quality, safety, and compliance of biological medicinal products.

Key Responsibilities:

Ensure compliance with the French Public Health Code
Guarantee adherence to GxP (GMP, GDP, GVP)
Act as the primary contact with ANSM
Set up the exploitant status in France
Oversee compliance of Marketing Authorizations and regulatory dossiers
Ensure appropriate licenses are maintained (MAH, manufacturer, importer)
Oversee or delegate batch release activities (in coordination with the Qualified Person if applicable)
Maintain the Pharmaceutical Quality System (QMS)
Approve key quality procedures
Supervise deviations, CAPAs, change controls, and OOS investigations
Oversee pharmacovigilance systems (in coordination with PV responsible person)
Ensure proper reporting of adverse events
Approve promotional and scientific materials
Ensure compliance with GDP (Good Distribution Practices)
Oversee storage, distribution, and import/export activities
Manage product recalls and quality complaints
Lead preparation for ANSM inspections and partner audits
Ensure implementation of corrective and preventive actions
Support, as needed, some activities related to other European countries

Qualifications:

Doctor of Pharmacy (PharmD or equivalent)
Mandatory registration with the French Order of Pharmacists (Section B or C depending on activity)
Significant experience in pharma/biotech industry
Background in Quality, Manufacturing, or Regulatory Affairs
Experience in rare disease
Experience with regulatory inspections (ANSM/EMA)

Key Skills:

Responsible Pharmacist (Pharmacien Responsible)

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