This is a fully Remote and Work From Home (WFH) opportunity within the US

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention and a more representative patient population. To help us achieve our goal, we are seeking an Associate Director of Vendor Quality Management eager to make an impact within a mission-driven organization. 


The Associate Director of Vendor Quality Management will represent Science 37 Quality and Compliance’s key interests with regard to vendor quality management including, but not limited to: risk assessment and mitigation, initial qualification, periodic quality assessment, requalification, ongoing quality management, investigation and resolution of quality concerns, and KPI development and monitoring, as applicable.  This role will also oversee Quality Management Agreements in which Science 37 is the vendor and fulfillment of the associated requirements.

DUTIES & RESPONSIBILITIES

Duties include but are not limited to:

  1. Represents Quality and Compliance interests in the vendor and systems assessment process
  2. Coordinates, performs and oversees completion of vendor qualification and requalification activities, as appropriate
  3. Administers the periodic vendor quality assessment process
  4. Liaises with other key stakeholders, internally and externally, to lead, support and monitor vendor quality issue investigation, root cause analysis, corrective and preventive actions, and effectiveness verification checks through completion, as appropriate
  5. In partnership with procuring department lead (e.g. Clinical Operations) and other stakeholders, assesses the need for quality-related KPI definition, implementation and monitoring
  6. Liaises with the head of Procurement and or their designee(s) on topics of mutual interest including, but not limited to: results of periodic vendor assessments, vendor quality metrics, and vendor quality or performance concerns
  7. Oversees Sponsor Quality Management Agreements in which Science 37 is the vendor; ensures fulfilment of the necessary requirements such as notifications, KPIs and governance-related activities
  8. Support procuring department lead and other stakeholders in ongoing risk identification, assessment and mitigation as relates to the vendor’s product or service offering
  9. Drives the continued refinement and improvement of the vendor qualification and oversight processes
  10. Remain abreast of current, evolving and new regulations, guidance, and industry best practice

QUALIFICATIONS & SKILLS

Qualifications

  1. Bachelor’s Degree in science, engineering, or another related field required
  2. 6+ years of experience in quality or compliance in clinical research, biotechnology, or other GxP or regulated environment, or requisite combination of education, training and experience
  3. Knowledge of cGxP regulations and industry best practices

Skills/Competencies

  1. Excellent organizational and project management skills; able to track and manage complex processes from start to finish
  2. Analytical and problem-solving skills, with ability to operate at all organization levels
  3. Strong and effective verbal and written communication skills with the ability to customize approach for a variety of audiences 
  4. A track record of successful cross-functional leadership and delivery through collaboration and effective relationships
  5. Extraordinary focus on details, analysis and results including ability to work on complex issues with multiple dependencies and stakeholders to drive consensus
  6. Ability to tactically implement a strategic vision

Capabilities

  1. Ability to communicate in English (both verbal and written)

REPORTING
The incumbent reports to the Director of Quality and Compliance.

DIRECT REPORTS
None.


Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

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