Head of Product Complaints & Quality

Resilience; Port Union (OH); On-site; USD 115,000 - 183,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Medical, dental, vision coverage

Tuition reimbursement

Paid vacation

Paid holidays

Paid leaves of absence

Caregiving support

Job summary

Resilience is seeking a Senior Manager, Product Complaints to own and drive the product complaints program, ensuring timely evaluation, investigation, and closure in compliance with GMP and regulatory requirements.

You will lead cross‑functional teams, set program goals, monitor KPIs, and communicate findings to clients and regulators, while developing staff and driving continuous quality improvement across the organization.

Qualifications

• Expert knowledge of cGMP in Pharma/Biotech with ICH/ISO guidelines.
• Ownership of a complaint/investigation program with regulatory commitments.
• Experience leading teams and cross‑functional partners without direct authority.
• Strong project management and technical writing skills.

Responsibilities

• Own the Product Complaints program, ensure timely evaluation, investigation, and closure.
• Lead complaint intake, triage, investigation, and escalation when needed.
• Ensure regulatory compliance and timely delivery per Quality Agreements.
• Prepare quarterly/annual trend reports for site and global leadership.
• Communicate findings to clients and regulators; manage client inquiries.
• Design and implement process improvements in complaint handling.
• Lead cross‑functional teams to resolve complaints and prevent recurrences.
• Review and approve investigations and related documentation.
• Define KPIs, set team goals, and address adverse trends.
• Represent the program during audits/inspections and manage readiness.

Skills

cGMP knowledge

Regulatory compliance

People leadership

Quality program management

Investigation leadership

Cross-functional collaboration

Quality metrics & KPIs

Technical writing

Education

Science/technical degree

Advanced degree orMBA

ASQ certifications (CQA, CQE, CQM)

Job description

Resilience is seeking a Senior Manager, Product Complaints to own and drive the product complaints program, ensuring timely evaluation, investigation, and closure in compliance with GMP and regulatory requirements.

You will lead cross‑functional teams, set program goals, monitor KPIs, and communicate findings to clients and regulators, while developing staff and driving continuous quality improvement across the organization.