Department: Quality

Director, Quality Assurance

Summary:

The Director of Quality Assurance (QA) will establish, manage and execute Quality Management system (QMS) and processes, ensuring comprehensive and integrated TB Alliance practices for good clinical, manufacturing and laboratory practices and mechanisms for continuous improvement. Position reports to Chief Administrative Officer (CAO).

Position description:

  • Oversee establishment and communication of Quality principles and standards and ensure alignment of all Quality activities across the organization as outlined in the Quality Manual.
  • In coordination with functional leadership, establish annual program goals and monitor progress to both sustain compliance and contribute to continuous improvement.
  • In coordination with CAO, ensure senior level visibility, integration of Quality activities across the organization, and appropriate internal escalation of compliance risks and issues.
  • Coordinate Quality program initiatives, such as third-party oversight program with specific emphasis on 1/Annual Audit Program 2/ Controlled Documents 3/ Issues Management/CAPAs.
  • Oversee internal documentation practices internally to ensure all practices are compliant and sustained.
  • Serve as focal point across the organization and with outside advisors, coordinating with functional leaders and external subject matter experts as required (e.g. GMP, GLP, PV).
  • Maintain up to date knowledge of GxP standards and developments. Serve as a mentor and subject matter expert on Quality practices.
  • Assess staff training needs and implement and maintain a GxP training program.
  • Manage all Clinical department Quality obligations, including PV, to ensure consistency of practice across clinical trials and adherence with SOPs.
  • Review Clinical contracts for quality adherence.
  • Plan and execute internal and external audits, in particular for clinical sites and vendors involved in clinical trials.
  • Responsible for compliance with applicable GxP regulations in performing the functions of the job and attendance at annual GxP or other applicable regulatory trainings provided by the TB Alliance.

Ideal candidates will have:

  • Minimum of bachelor’s degree in scientific or relevant discipline. Advanced degree and/or GxP related certification preferred
  • 10+ years of relevant life science, pharmaceutical development and/or CRO experience, with 3-5 years Quality and/or Regulatory experience
  • Working knowledge of ICH regulatory requirements and compliance practices
  • Experience in vendor selection, contract review, and budget tracking
  • Experience with clinical trials in high burden TB countries preferred
  • Exceptional organizational skills
  • Consistent, reliable, detail oriented and collaborative
  • Excellent communication and negotiation skills
  • Comfortable with matrix environment
  • Proven ability to work well and effectively in a team global, virtual environment
  • Demonstrated experience at building and maintaining strong long-term professional working relationships
  • A sense of purpose and dedication to the objectives and mission of the Global Alliance for TB Drug Development and it’s not for profit focus

Location:

Organizational Information:

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster, affordable tuberculosis drugs that are available to those who need them.Through innovative science and with partners around the globe, we lead a global effort to ensure development of and equitable access to faster, better tuberculosis cures that will advance global health and prosperity.

With an annual operating budget of approximately $60 million, the TB Alliance leads the advancement of the most comprehensive R&D portfolio of TB drug candidates in history. Additionally, the TB Alliance drives efforts to ensure regulatory approval, country adoption of new regimens, and widespread availability of new drug regimens to patients. For more information, please access the website: www.tballiance.org.

Our Pipeline

TB Alliance manages the largest pipeline of new TB drugs in history.

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