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

Reference #: 2025-87878

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 closeprojectswith close collaboration with IT, Quality, Regulatory Affairs, and Operations teams.

Leadsprojects

Leads projectsthrough issues, roadblocks, andproblems

Acts as a change agent to drive teams toward success

Guides team members to perform through issues andconstraints

Owns projects

Owns the timeline, budget, resource constraints, and deliverables/results

Shifts between the big picture and the small-but-crucialdetails

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,Ganttchart, status updates)

Communicates

Actively communicates with project sponsors and stakeholders

Establishes regular points ofcommunication

Manages sponsor and stakeholdersexpectations.

Delivers the expectedresults

Performs root cause analysis on project shortfalls andtakes corrective action asnecessary

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 oflarge,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 anddeliverables

Participates in Communities of Practice

Documentsbusiness processes

Qualifications

Required WorkExperience:

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

Demonstrated ability to develop strong relationships withothers

Demonstrated experience leadingchanges

Demonstrated ability t influence businessleaders

Some experience with process management

Basic knowledge of VOC tools

General knowledge of Hoshin and breakthrough planning

Skills:

Demonstrated data analysisskills

Problemsolvingskills

Effective written and verbalcommunication skills across multiple formats:formal presentations, meetings, conference calls,e-mails,andmemos

Skilledin Microsoft Word, Excel, PowerPoint, and Project

Interpersonal skills

Decision makingskills

Planning and organization skills

Negotiation skills

Results-oriented

Creative

Persistent

Composed

Able to learn new conceptsrapidly

Able to work independently with littlesupervision

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)

or any other legally protected status.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets