Senior Quality Specialist

The Senior Quality Specialist is responsible for assisting Quality Leadership with ensuring compliance and quality processes are maintained in support of clinical trial operational activities. The Senior Quality Specialist will serve as chief administrator for the quality management software (QMS) and is responsible for development, configuration and management of the QMS. 

Essential Duties and Responsibilities

• Leads and project manages QMS activities including document control, change control, non-conformance reporting and supplier qualification/requalification 

• Serves as team lead CSV specialist 

• Responsible for data reduction, metrics and managerial reports delivery 

• Supervise and assist in management of QMS Non-Conformance reporting and their related investigation, root cause analysis, proposed corrective and/or preventive measures, and due diligence thereto 

• Trains QMS users on workflow and associated tasks for modules within the QMS 

• Leads eQMS configuration and improvement specialist 

• Assesses, creates, and presents QMS Lean and Process Efficiency opportunities and projects 

• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses 

• Provide industry leading QMS compliance guidance and quality assurance consultation to internal and external stakeholders 

• Clear and concise communication of QMS reporting for regulatory and quality consulting advisements 

• Schedules and conducts monthly quality review meetings as required 

• Prepare training materials and conduct training for QMS topics 

• Collaborates with Human Resources regarding training program requirements affected by the QMS 

• Serves as Quality subject matter expert for configurable systems validation projects 
• Conducts research, and compiles and types statistical reports 
• Performs other tasks as defined by the Quality Assurance Leadership 

Education and Experience

• 4 -year degree preferred with 5-7 years of Quality Assurance Experience; or a 2-year degree with 8-10 years related experience and/or training; or equivalent combination of education and experience. 
• Veeva Belt certification preferred.

Skills and Ability

• Must possess strong organizational and interpersonal skills.  
• Experience with QMS platforms such as Veeva is highly preferred.  
• Proven track record of leading QMS implementations or enhancements is a strong asset. 

Supervisory Responsibilities:  None

Physical Demands:

While performing the duties of this job, the occupant is regularly required to:

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.

Travel Requirements:  Minimal