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Clinical Quality Director

2 months ago

Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full time
About Alkeus Pharmaceuticals, Inc.

We are a late-stage biopharmaceutical company dedicated to developing transformative therapeutics for serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration.

Our Mission

We strive to protect the rights, safety, and welfare of clinical patients by ensuring that our operations are compliant with US (FDA) and international regulations and guidance.

Responsibilities
  • Quality Oversight
    • Manage the GCP Quality functional area to ensure compliance with regulations and guidance.
    • Provide quality oversight of internal and external clinical functions.
  • GCP Subject Matter Expert
    • Act as a GCP Subject Matter Expert (SME) in GCP and GVP compliance.
    • Support the drafting and implementation of the Alkeus GCP/GVP Quality Management System SOPs.
  • Audit and Compliance
    • Manage the planning and execution of clinical site and CRO/Vendor audits.
    • Perform external and internal GCP audits and gap assessments.
    • Manage clinical site, CRO/Vendor, and internal CAPA closure for audit observations.
  • Regulatory Compliance
    • Review of clinical and data management operational plans and protocols.
    • Review of key safety, clinical, and regulatory documents.
  • Regulatory Inspections
    • Participate in preparing for, hosting, and supporting Health Authority/Regulatory inspections and internal/external audits.
    • Serve as an SME for areas of responsibility during regulatory inspections.
  • Continuous Improvement
    • Promote a culture of continuous improvement and cross-functional problem-solving.
    • Keep abreast of industry developments and forthcoming regulations.
Qualifications
  • Education
    • Bachelor's or Master's degree in a life science or healthcare field.
  • Experience
    • 8 to 10 years of GCP experience in drug and/or biopharmaceutical companies or in a Contract Research Organization (CRO) capacity.
    • Experience with small molecule drugs is a plus.
  • Skills
    • Demonstrated knowledge of Quality Systems, GCP, and PV within an FDA and EMA-regulated environment.
    • Ability to apply compliance and risk-based thinking to quality assessments and problem-solving.
    • Ability to influence change and process improvements internally and at clinical sites/CROs.
Experience
  • Clinical Quality Systems
    • 7+ years' experience with Clinical Quality Systems in the drug or biopharmaceutical fields.
  • GCP Auditing
    • At least 3 years of prior GCP auditing experience of clinical sites, CRO's, and Pharmacovigilance.
  • Regulatory Compliance
    • Experience in implementation and maintenance of Clinical Quality Systems.
    • Experience in training staff on GCP and GLP principles, processes, and procedures.
Travel
  • Willingness to Travel
    • Willingness to travel up to 20% on an as-need basis for performance of CRO, Vendor, or Clinical Site audits.