Senior Manager, Product Complaints & Quality Leadership

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

Benefits offered by this job

Annual bonus

401(k) match

Healthcare benefits

Family building benefits

Life insurance

Disability insurance

Paid vacation

Paid holidays

Other leaves

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a Senior Manager, Product Complaints to own the program for timely evaluation, investigation, and closure of product quality complaints in GMP compliance.

The role leads investigations, determines root cause, and ensures reportability decisions, CAPA initiation, and timely responses to audits, while mentoring staff and aligning with site leadership for continuous quality improvement.

Qualifications

• Expert knowledge of cGMP in pharma/biotech.
• Ownership of a complaint, deviation, or investigation program.
• Experience interpreting regulatory requirements and applying them to investigations.

Responsibilities

• Own intake, triage, and categorization of complaints with defined criticality.
• Lead investigations, determine root cause, and initiate CAPA.
• Ensure GMP and Quality Agreement compliance in all activities.
• Prepare quarterly/annual trend reports to leadership.
• Communicate findings to clients and regulators; respond to inquiries.
• Design process improvements with cross-functional partners.
• Lead cross-functional teams to resolve issues and prevent recurrence.
• Review/approve complaint investigations and documentation.
• Define KPIs; monitor performance and address negative trends.
• Represent the program during inspections by FDA and regulators.
• Ensure inspection readiness and staff readiness for audits.
• Lead, coach, and develop staff with performance reviews.

Skills

cGMP knowledge

Regulatory compliance

Quality investigation

People leadership

Cross-functional collaboration

Project management

Technical writing

Education

B.S. in science/technical field

Advanced degree or MBA

ASQ certifications (CQA/CQE/CQM)

Job description

Resilience, a technology-focused biomanufacturing company, seeks a Senior Manager, Product Complaints to own the program for timely evaluation, investigation, and closure of product quality complaints in GMP compliance.

The role leads investigations, determines root cause, and ensures reportability decisions, CAPA initiation, and timely responses to audits, while mentoring staff and aligning with site leadership for continuous quality improvement.