Job Details

Responsible for assigned operational Quality Risk and Compliance (QRC) activities supporting Research and Development (R&D) quality efforts, including inspection readiness (IR), process improvement, training, and other assigned duties. This role works closely with Quality Operations and internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs. 

• Audit and Inspection Readiness (IR)
  • Support Quality operations activities to ensure continuous audit and inspection readiness.
  • Assist with inspection preparation activities, including tracking and closure of IR actions across multiple parallel workstreams, preparation of meeting minutes, scheduling of meetings, coordinating trainings, etc.
  • Coordinate cross-functional input as needed to support timely and effective resolution of mock inspection Corrective and Preventive Actions (CAPA) and commitments.
  • Support regulatory inspections by serving as a scribe and processing inspection requests as assigned.
  • Assist with post-inspection activities, including implementation of lessons learned and follow-up actions.
  • Support development of dashboards, metrics, and visualizations (e.g., Smartsheet, Power BI) to monitor functional performance against assigned Inspection Readiness (IR) activities.

• Process Improvement/Project Management
  • Support coordination of and/or participate in process improvement initiatives.
  • Prepare and maintain meeting materials, project trackers, and metrics reports to support project execution, status reporting, and stakeholder communication.
  • Assist with process mapping and workflow documentation as needed.

• Training
  • Support biennial R&D curriculum reviews to ensure training assignments and content remain relevant, and compliant with applicable regulatory and quality requirements.
  • Help organize and prepare for quality-related training workshops.
  • Support identification and/or development of quality eLearning and other training offerings.
  • Track new and revised controlled documents, including follow-up with curriculum owners on training changes and processing of Adobe Forms.
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• Other Quality Operations Support
  • Prepare materials and facilitate QRC department meetings as assigned.
  • Support the Quality Risk Management group in developing, tracking and maintaining study quality, compliance and training metrics, as needed.
  • Other duties as assigned/required

• Detail-oriented with strong organizational, project management, and communication skills.
• Ability to manage multiple projects, workstreams, and activities while adapting to changing priorities.
• Strong interpersonal skills with ability to work effectively both independently and in cross-functional teams.
• Demonstrated analytical skills with ability to organize, evaluate and interpret data, metrics, trends.
• Working knowledge of clinical trials, GxP principles and Quality Management Systems.
• Proficient computer skills, including Microsoft Word, PowerPoint, Excel and related business applications.
• Experience with Veeva Systems, Power BI and Smartsheet software is preferred.
• This position follows a hybrid work model and requires a minimum of 60% on-site attendance in the office.
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• Receives assignments in the form of objectives.  Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors and an understanding of functional area objectives and trends.  Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization

Bachelor’s degree in Science or a related field with a minimum of 2 years of relevant experience within the pharmaceutical or biotech industry, including experience in Quality, Clinical Operations, Project Management and/or other R&D function.  An equivalent combination of relevant education and experience may be considered.