Job Summary

Position Summary

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).

Key Responsibilities

Remediation Program Leadership

• 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

Quality System Improvement

• 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)

Governance & Reporting

• 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

Cross-Functional Coordination

• 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

Risk Management

• Identify assess and proactively mitigate risks impacting remediation timelines or compliance outcomes
• Ensure traceability between issues root causes corrective actions and verification activities

Audit & Inspection Readiness

• Support internal and external audits including preparation response coordination and closure of findings
• Ensure remediation deliverables meet regulatory expectations for completeness clarity and traceability

Required Qualifications

• Bachelors 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

Preferred Qualifications

• 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)

Key Competencies

• Execution under pressure Ability to deliver in time-sensitive high-stakes remediation environments
• Structured problem solving Strong root cause analysis and data-driven decision making
• Stakeholder influence Effective communication at all organizational levels including executives
• Attention to detail & compliance mindset Ensures rigor traceability and audit readiness
• Program governance excellence Drives accountability and transparency across complex initiatives

Success Metrics

• On-time closure of CAPAs and remediation milestones
• Reduction in repeat findings / audit observations
• Improved quality system performance metrics
• Audit/inspection outcomes (no major observations tied to remediated areas)
• Stakeholder alignment and program predictability

Environment & Scope

• Works in a global cross-functional environment
• High visibility with senior leadership

MF15

What youll receive for the great work you provide:

• Full range of medical dental and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Application Deadline:

Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.

The base pay range for this position is provided below. The final base rate offered will be determined using job-related non-discriminatory criteria including but not limited to experience qualifications geographic location education external market data and internal equity.

Job Category

Is Sponsorship Available