Sr. Associate, Quality Operations

Job Description

Job Summary:

• 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 aProductst 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.

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.

Education and Experience:

• 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.

Knowledge, Skills, and Abilities:

• 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
  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 Product 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.