Sr. Associate, Quality Operations
1 Year Contract with high possibilities of extension
Princeton, NJ (Hybrid) Schedule: Hybrid
Onsite in Princeton Monday through Wednesday, with Thursday and Friday remote Duties 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.
- 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.
- 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.
- 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.
- 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. #TechAM
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