Quality Remediation Program Manager

Description - QUALITY REMEDIATION PROGRAM MANAGER INTAKE NOTES:
Pay Rate: TBD
Remote or Hybrid
Ideal candidate has strong experience supporting the 483/warning letter work; navigating regulations
Candidates who have a military background, tangible experience with Aerospace or Automotive, and Pharmaceuticals are natural fits for this work

The Quality Program Manager is responsible for leading, coordinating, and governing the execution of multiple critical workstreams within the enterprises FDA 483/Warning Letter remediation program. Operating at a program level within the Quality PMO, this role ensures that all remediation activities are planned, executed, monitored, and completed in strict alignment with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR requirements. This individual establishes program governance, drives cross-functional accountability, manages interdependencies across Design Controls, Risk Management, CAPA, Complaints, Management Controls, QMS remediation, and Data Analytics, and ensures that the organization delivers sustainable, audit-ready improvements to the Quality Management System.
The Quality Program Manager is a seasoned professional who demonstrates advanced program management skills, excellent communication, and the leadership presence required to coordinate across all levels of the organization, including senior management, consultants, and regulatory stakeholders. Essential Duties and Responsibilities: The table below outlines the key activities and competencies required for each knowledge category. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Area Key Activities
Program Leadership & Governance Lead program-level planning, execution, oversight of multiple remediation workstreams, ensure compliance with Warning Letter/483 commitments, establish governance structures, program schedules, status reporting, dashboards, decision logs, escalation pathways, define objectives, metrics, success criteria, Quality PMO standards, ensure alignment between workstreams and master schedule, manage cross-functional dependencies

Regulatory & Quality System Remediation
Ensure remediation activities comply with FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR, drive correction across Design Controls (820.30), Risk Management (ISO 14971), CAPA & NCE/Nonconformance, Complaints & Investigations (820.198), MDR / Field Actions (803 & 806), Management Controls (820.20), QMS Process Remediation, Procedure Harmonization, Data Analysis & Sharing, review and validate documentation packages
Cross-Functional Leadership & Communication Lead cross-functional forums, alignment sessions, integrated meetings, partner with Quality, Regulatory, R&D, Operations, Service, IT, Clinical, Manufacturing, provide program updates to senior leadership, maintain configuration control, evidence tracking for remediation deliverables Risk Management & Escalation Identify and assess program-level risks, barriers, systemic issues, develop risk mitigation strategies, ensure escalation per governance, support root cause methodologies, risk-based prioritization, effectiveness verification strategies Sustainable Quality System Improvement Drive long-term improvements, prevent recurrence, elevate organizational maturity, work with process owners to implement enhancements to procedures, templates, training, governance, tools, systems, promote culture of quality accountability, transparency, continuous improvement

Physical Demands: The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Sit; use hands to finger, handle or feel objects, tools, or controls. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. Travel (please specify): up to 25%

Qualifications: Education

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Technical Bachelors Degree

Experience: 58 years of experience in project or program management in a regulated medical device environment.

• Demonstrated experience leading projects involving FDA 21 CFR 820 and ISO 13485 compliance, including Design Controls, CAPA, Complaints, MDR, or QMS remediation.
• Experience supporting or leading FDA inspection response, Warning Letter remediation, or 483 corrective actions strongly preferred.
• Experience with Design Control, Quality Systems, and risk-based process improvements.
• Prior experience in large-scale cross-functional quality remediation or transformation programs beneficial. Skills Strong understanding of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
• Excellent communicator with strong presentation skills, capable of interfacing with senior leaders, consultants, and regulatory stakeholders.
• Proficient in building integrated schedules, risk registers, dashboards, and PMO governance artifacts (Microsoft Project, Smartsheet, Planview, etc.).
• Skilled in root cause analysis methodologies, data-driven decision-making, and structured problem solving. Detail oriented, highly organized, and able to manage multiple priorities under urgent timelines.