Project Manager - Quality Remediation Programs

Flex•Buffalo Grove, IL

1d•$89,200 - $122,700•Onsite

About The Position

The Project Manager – Quality Remediation Programs is responsible for leading complex, cross-functional remediation initiatives to address quality system gaps, regulatory findings, and operational risks. This role drives execution of corrective and preventive actions (CAPA), ensures compliance with applicable standards (e.g., ISO 13485, FDA, GMP), and restores sustainable quality system performance. The role requires strong program governance, stakeholder alignment, and the ability to operate under high-pressure, high-visibility conditions (e.g., audit observations, warning letters, or compliance commitments).

Requirements

Bachelor’s degree in Engineering, Quality, Life Sciences, or related field
7+ years of experience in project/program management within a regulated industry (medical device, pharma, aerospace, etc.)
Proven experience leading quality remediation or compliance transformation programs
Strong knowledge of quality systems (e.g., CAPA, ISO 13485, FDA QSR, GMP)
Demonstrated ability to manage cross-functional teams in high-pressure environments

Nice To Haves

PMP or equivalent project management certification
Experience supporting regulatory inspections (FDA, notified bodies, customers)
Background in quality engineering, regulatory affairs, or manufacturing operations
Familiarity with digital quality systems (eQMS platforms)

Responsibilities

Lead end-to-end execution of quality remediation programs, including scope definition, planning, execution, and closure
Establish and manage integrated project plans covering CAPA, nonconformance remediation, process improvements, and documentation updates
Ensure alignment with regulatory commitments, audit responses, and compliance timelines
Partner with Quality and Operations teams to identify systemic gaps and drive sustainable fixes
Oversee development and implementation of CAPA plans, ensuring effectiveness checks and closure rigor
Drive standardization and improvement of quality processes (e.g., DHF/DMR, change control, risk management, TMV)
Establish robust governance structure including executive reviews, program dashboards, and escalation pathways
Track and report remediation progress, risks, and key performance indicators (KPIs) to senior leadership
Ensure documentation readiness for audits and regulatory inspections
Coordinate activities across Engineering, Operations, Quality, Supply Chain
Remove barriers and resolve conflicts to maintain program timelines
Align internal teams and external partners on deliverables and expectations
Identify, assess, and proactively mitigate risks impacting remediation timelines or compliance outcomes
Ensure traceability between issues, root causes, corrective actions, and verification activities
Support internal and external audits, including preparation, response coordination, and closure of findings
Ensure remediation deliverables meet regulatory expectations for completeness, clarity, and traceability