Senior Manager, Product Complaints & Quality Improvement

Resilience; Blue Ash (OH); On-site; USD 115,000 - 183,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Health insurance (medical, dental, and

Vision coverage

Job summary

Resilience seeks a Senior Manager, Product Complaints to own the program ensuring timely evaluation, investigation, and closure of quality complaints in GMP compliance. Leads investigations, trends, and cross-functional remediation while serving regulators and clients.

The role represents the site in audits, drives KPI targets, and oversees staffing, budget, and escalation decisions to protect patient safety and site operations.

Qualifications

• Expert knowledge of cGMP in pharma/biotech with regulatory awareness.
• Experience owning a complaint/investigation program and metrics.
• Knowledge of pharmaceutical processes and quality systems.
• Ability to defend conclusions to regulators and leadership.
• Leadership experience and cross-functional collaboration skills.

Responsibilities

• Own the product complaints program, ensure timely evaluation and closure.
• Lead investigations and CAPA initiation with cross-functional teams.
• Prepare complaint trend reports for leadership and regulators.
• Communicate findings to clients and regulatory agencies.
• Drive process improvements and maintain documentation.

Skills

cGMP knowledge

Quality Assurance

Regulatory compliance

Root cause analysis

Project management

Education

Bachelor's degree in science/technical field

Job description

Resilience seeks a Senior Manager, Product Complaints to own the program ensuring timely evaluation, investigation, and closure of quality complaints in GMP compliance. Leads investigations, trends, and cross-functional remediation while serving regulators and clients.

The role represents the site in audits, drives KPI targets, and oversees staffing, budget, and escalation decisions to protect patient safety and site operations.