Sr. Program Manager, Quality Assurance/Regulatory Affairs (Hybrid)

The Sr. Program Manager, Quality Assurance/Regulatory Affairs will lead a variety of large projects or programs within the Quality & Regulatory Affairs organization with special focus on deployment of an enterprise-wide electronic Quality Management System (eQMS).  This position will be responsible for overseeing the planning, execution, integration, and optimization of the eQMS technology across Quest Diagnostics’ business units, laboratories, ensuring alignment with regulatory requirements (FDA, CAP, CLIA, ISO etc.) industry best practices, and internal quality objectives

This is a hybrid role, and The Sr. Program Manager will work from a major Quest Diagnostics site 3 days per week. Sites may include Marlborough, MA, Pittsburgh, PA, Baltimore, MD, Tucker, GA, Miami, FL, Wood Dale, IL, Lenexa, KS, Houston, TX, Dallas, TX, etc.

Responsibilities

• Leads end to end implementation of e-QMS technology across multiple functional areas including Document Control, CAPA, Change Control, Audit Management, Training, and Complaint Management.
• Leads projects and working teams to effectively initiate, plan, execute, monitor, and close projects with close collaboration with IT, Quality, Regulatory Affairs, and Operations teams.
• Leads projects 
  • Leads projects through issues, roadblocks, and problems 
  • Acts as a change agent to drive teams toward success
  • Guides team members to perform through issues and constraints 

• Owns projects
  • Owns the timeline, budget, resource constraints, and deliverables/results
  • Shifts between the big picture and the small-but-crucial details 
  • Is prepared to roll up their sleeves and work through detailed issues

• Manages projects 
  • Ensures all appropriate tools are completed and used effectively (e.g., charter, Gantt chart, status updates) 

• Communicates
  • Actively communicates with project sponsors and stakeholders
  • Establishes regular points of communication 
  • Manages sponsor and stakeholders expectations. 

• Delivers the expected results 
  • Performs root cause analysis on project shortfalls and takes corrective action as necessary 

• Serve as a liaison between internal stakeholders, and external vendors/partners to ensure smooth system integration and configuration.
• Facilitate user requirements gathering, system design specifications, validation planning, and change management strategies.
• Leads or coordinates validation activities for business deliverables such as data migration verification, PQ, or UAT
• Ensure the eQMS is implemented in compliance with applicable regulations (21 CFR Part 11, ISO 13485, GxP) and partners closely with Quality Systems to ensure Quality management system readiness and adoption of new processes
• Lead training, communication, and organizational readiness efforts to support successful adoption and sustained use of the system
• Applies project management tools and techniques toward a variety of large, and likely inter-related, projects 
• Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables 
• Participates in Communities of Practice 
• Documents business processes 

Qualifications

Required Work Experience:  

Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion within a regulated healthcare, diagnostics, medical device, or pharmaceutical environment (7-10 years experience) 

Knowledge:  

• Direct experience leading eQMS implementations (e.g. Veeva, MasterControl, TrackWise, ETQ, ComplianceQuest)
• Demonstrated knowledge of FDA, ISO, GxP and other relevant quality and regulatory standards
• Strong experience with computer system validation (CSV) and Part 11 compliance
• Demonstrated experience facilitating discussions or workshops  
• Demonstrated ability to develop strong relationships with others 
• Demonstrated experience leading changes 
• Demonstrated ability to influence business leaders 
• Some experience with process management 
• Basic knowledge of VOC tools 
• General knowledge of Hoshin and breakthrough planning 

Skills:  

• Demonstrated data analysis skills 
• Problem solving skills 
• Effective written and verbal communication skills across multiple formats:  formal presentations, meetings, conference calls, e-mails, and memos   
• Skilled in Microsoft Word, Excel, PowerPoint, and Project 
• Interpersonal skills 
• Decision making skills 
• Planning and organization skills 
• Negotiation skills 
• Results-oriented  
• Creative 
• Persistent 
• Composed 
• Able to learn new concepts rapidly 
• Able to work independently with little supervision 

Education
Bachelor’s Degree (Required)

Licenses/Certifications
Formal training in project management or continuous improvement methodologies (e.g., Six Sigma, Total Quality Management, Lean, Theory of Constraints)
PMI Project Management Professional (PMP) (Strongly Preferred)

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.