Senior Product Complaints & Quality Lead

Resilience; West Chester (IA); On-site; USD 115,000 - 183,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Healthcare benefits (medical, dental,

Vision

Life and disability insurance

Paid vacation

Paid holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is a technology-focused biomanufacturing company transforming how medicine is produced. The Senior Manager, Product Complaints owns the product complaints program, ensuring timely evaluation, investigation, and closure of quality complaints in compliance with GMP and regulatory requirements.

The role drives improvements, sets goals, and leads complaint handling staff, interfacing with site leadership, global quality, clients, and auditors.

Qualifications

• Expert knowledge of cGMP in pharma/biotech, incl. FDA/EU/JP and ICH/ISO guidelines.
• Ownership of a complaint/investigation program and program-level metrics.
• Experience leading cross-functional teams and managing timelines.

Responsibilities

• Own the Product Complaints Program and drive timely evaluation, investigation, and closure of product quality complaints.
• Lead root cause analysis, CAPA initiation, and reportability decisions with cross-functional teams.
• Ensure compliance with GMP and regulatory requirements and prepare trend reports for leadership.
• Represent the program during audits and regulatory inquiries; communicate findings to clients and regulators.

Skills

cGMP knowledge

Regulatory compliance

Quality assurance

Investigation leadership

Cross-functional leadership

Project management

Education

Bachelor's degree in science/technical field

Advanced degree or MBA

Job description

Resilience is a technology-focused biomanufacturing company transforming how medicine is produced. The Senior Manager, Product Complaints owns the product complaints program, ensuring timely evaluation, investigation, and closure of quality complaints in compliance with GMP and regulatory requirements.

The role drives improvements, sets goals, and leads complaint handling staff, interfacing with site leadership, global quality, clients, and auditors.