Senior Director/Executive Director, Quality

Company: Prilenia
Location: Boston
Posted on: September 2, 2024

Job Description:

About Prilenia Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Senior/Executive Director of Quality to join its team in Europe. We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington's disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine's novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases. About the roleWe seek a highly qualified and experienced professional to join our team as the Head of Quality. This position will provide both overall direction and hands-on operational execution in establishing, implementing, and maintaining a phase-appropriate and continuously evolving Quality Management System (QMS). The ideal candidate will have background in late clinical stage and first commercialization of products including GCP, GMP, GVP and other relevant GxP, with a pragmatic true fit-for-purpose approach.The position will report to the Chief Operating Officer.Roles and Responsibilities:

• Lead the development, implementation, and continuous improvement of a phase-appropriate Quality Management System (QMS), including policies, processes, and procedures.
• Collaborate with internal functions to assure effective vendor selection, qualification, and oversight to ensure clinical trials and other outsourced GxP activities are conducted in accordance with all relevant laws, regulations, and guidelines.
• Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures.
• Create, implement, and oversee audit plans for CROs, CDMOs and other GxP vendors. Assess and respond to audit outcomes.
• Lead preparations for regulatory inspections and ensure ongoing inspection readiness.
• Provide GCP advice and audit for clinical studies to ensure they are conducted in accordance with FDA, EMA, ICH and other applicable requirements, guidelines and laws.
• Identify any training requirements to meet the quality standards and ensure training is completed.
• Maintain and expand regulatory knowledge, to the ICH Principles of GCP, GMP, General Data Privacy Regulation and International GxPs; provide industry leading compliance guidance and quality assurance consultation to internal and external stakeholders.
• Manage all relevant external QA vendors e.g. quality auditors, consultants, etc.Qualifications:
  • 10+ years of experience in QA roles with a mix of Biotechnology/Pharmaceutical and/or CMO/CRO companies. At least part of the time should have been in a small to medium sized biotech or pharma company.
  • In-depth understanding and application of GxP principles, concepts, practices, and standards.
  • Demonstrated experience in establishing and managing quality systems in small to mid-sized companies.
  • Thorough understanding of GCP and GMP standards for late clinical and early commercialization stages; as well as of both US and EU requirements.
  • Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory - required. In-depth knowledge in international regulatory landscape - preferred.
  • Proven experience in building key metrics, reporting, and enhancing recruitment technology and systems to influence decision-making and provide compelling story telling.Skills:
    • Excellent oral, written and interpersonal communications skills to effectively interact, and exercise discretion, judgment and diplomacy when dealing with internal and external stakeholders and executive leadership.
    • Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk. Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
    • Pragmatic and practical approach; understanding of "fit for purpose" approach.
    • Team player with positive attitude who can easily handle shifting priorities, multi-tasking in a deadline-oriented environment. Must be able to work under pressure, manage time, set priorities and meet deadlines.
    • Highly independent.
    • Experience working in virtual and global setting.
    • Ability to take initiative, be accountable for individual and team results, motivate self and others to set and achieve very high-performance standards.Location/Time Zones:
      • This is a full-time remote position in Europe or US, eastern time zone preferred.
      • Flexible schedule with interactions across Israel, North America and Europe time zones.
      • Occasional travel is expected.
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Keywords: Prilenia, Boston , Senior Director/Executive Director, Quality, Executive , Boston, Massachusetts