Enable job alerts via email!

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

Davita Inc.

Pittsburgh (Allegheny County)

Hybrid

USD 100,000 - 130,000

Full time

3 days ago
Be an early applicant

Boost your interview chances

Create a job specific, tailored resume for higher success rate.

Job summary

A leading company in the healthcare sector seeks a Sr. Program Manager for Quality Assurance/Regulatory Affairs to lead eQMS implementation across its business units. The successful candidate will manage large scale projects, ensuring compliance with regulations and standards while driving success through collaboration and communication.

Qualifications

  • 7-10 years in project management in healthcare or related field.
  • Experience leading eQMS implementations.
  • PMP certification preferred.

Responsibilities

  • Oversee eQMS projects including implementation across functional areas.
  • Coordinate with stakeholders and manage expectations.
  • Conduct root cause analysis for project shortfalls.

Skills

Data Analysis
Problem Solving
Effective Communication
Planning and Organization
Negotiation

Education

Bachelor's Degree

Tools

Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Project

Job description

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 to 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)


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

Get your free, confidential resume review.
or drag and drop a PDF, DOC, DOCX, ODT, or PAGES file up to 5MB.

Similar jobs

Senior Federal Subcontracts Administrator, Fully Remote options

AECOM

Pittsburgh

Remote

USD 77.000 - 129.000

2 days ago
Be an early applicant

Senior Project Controls Specialist (Remote Options)

Lensa

Pittsburgh

Remote

USD 89.000 - 148.000

12 days ago

Sr Analyst, Compliance & Licensing

Kiavi Funding, Inc.

Pittsburgh

Remote

USD 82.000 - 120.000

13 days ago

Cloud DevOps Administrator - (Remote)

TieTalent

Pennsylvania

Remote

USD 95.000 - 109.000

9 days ago

IT Director of Program Management & Configuration

Merakey

Whitemarsh Township

Remote

USD 119.000 - 140.000

Yesterday
Be an early applicant

Senior Therapeutic Area Specialist, Neuroscience Cobenfy – Canton, OH

Bristol-Myers Squibb

Wheeling

Remote

USD 90.000 - 130.000

9 days ago

Specialist QA- US Remote

Lensa

Washington

Remote

USD 90.000 - 130.000

Today
Be an early applicant

Senior Statistical Programmer - FSP - ( Permenant,homebased/remote) Evergreen

Lensa

Remote

USD 92.000 - 102.000

Today
Be an early applicant

Business Intelligence Lead

CenterWell Home Health

Kentucky

Remote

USD 117.000 - 162.000

-1 days ago
Be an early applicant