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Engineer Tools and Processes

Akebia Therapeutics

Engineer Tools and Processes

Cambridge, MA
Full Time
Paid
  • Responsibilities

    Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.  Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you?

    The Director of Standards and Compliance provides leadership and operational oversight of the development and implementation of SOPs, training and compliance for the clinical and related functions within the R&D organization including Biometrics, Clinical Development, Clinical Operations, Medical Writing, Pharmacovigilance, Regulatory etc). Establishes the vision and strategy for innovative and effective business processes and associated learning programs in support of clinical trial execution. Ensures inspection readiness and compliance for the clinical organization. Establishes best practices in process ownership and development.

    Responsible and accountable for establishing operational standards and managing a quality-oriented platform to deliver associated learning programs for conducting development programs and tracking and trending compliance.  This platform includes coordinating the development of standard procedures affecting the organization within established time frames and compliant with applicable clinical and regulatory guidelines and practices.

    The Director, Standards and Compliance is a strategic partner with functional and executive leadership to establish and maintain alignment with business vision, objectives and priorities. The Director, Standards and Compliance works with cross functional teams to develop appropriate policies, procedures, systems, and tools to ensure regulatory compliance for global clinical research. This individual will work in a team-oriented environment and engage in a wide range of activities, focused on policies, processes, staff training and clinical compliance initiatives.  The role is also responsible for recognizing, documenting, and assisting in escalating risks relevant to GCP/GXP/GVP activities.

    Required Skills

     

    • Development and oversight of assigned Akebia controlled documents (policies, procedures, forms, etc.)
    • Internal assessments of compliance with external and internal standards
    • Lead on behalf of identified R & D personnel, issue/incident/deviation investigation, assessment and actions including opening of a CAPA, SOP deviation reporting and ensuring follow-up on requirements to report to healthy authority(ies)
    • Manage the development and completion of assigned CAPAs and other risk mitigation actions for the R&D organization
    • Ensure R&D functions compliant with required personnel training (including evidence of training) on assigned controlled documents and relevant topics
    • Provide leadership and direction to the organization in ensuring GCP/GPV inspection readiness of the organization, its vendors, and its clinical investigators/sites in conjunction with Clinical Operations, Quality and other functions, as applicable

    Required Experience

    BASIC QUALIFICATIONS:

    • Bachelor’s Degree

    PREFERRED QUALIFICATIONS:

    • Bachelor’s degree in science
    • Minimum of 12+ years of pharmaceutical experience with 10+ years of direct experience in supporting global clinical programs with standards and compliance including health authority inspections.
    • Must have advanced and thorough knowledge related to ICH/GCP Guidelines and/or federal regulations, and applicable local regulations.
    • Experienced in the development and application of standard business procedures (SOPs, global regulations, ethics and compliance, outsourcing).
    • Participates in and is key contributor to initiatives and advancement of BPD organization infrastructure.
    • Ability to work efficiently and effectively in dynamic, changing environment with competing projects and deadlines.
    • Experience working in a global environment.
    • Builds/drives relationships and teamwork within team and across functions with professional demeanor. 
    • Willingness to take on responsibility and display initiative both in the functional and team environment.

    ARE YOU AN AKEBIAN?

    An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian’s aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian’s believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

    Akebia is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

    #LI-MS1

     

  • Qualifications

     

    • Development and oversight of assigned Akebia controlled documents (policies, procedures, forms, etc.)
    • Internal assessments of compliance with external and internal standards
    • Lead on behalf of identified R & D personnel, issue/incident/deviation investigation, assessment and actions including opening of a CAPA, SOP deviation reporting and ensuring follow-up on requirements to report to healthy authority(ies)
    • Manage the development and completion of assigned CAPAs and other risk mitigation actions for the R&D organization
    • Ensure R&D functions compliant with required personnel training (including evidence of training) on assigned controlled documents and relevant topics
    • Provide leadership and direction to the organization in ensuring GCP/GPV inspection readiness of the organization, its vendors, and its clinical investigators/sites in conjunction with Clinical Operations, Quality and other functions, as applicable
  • Industry
    Transportation / Trucking / Railroad