Senior Manager, Product Complaints

Resilience

. Own the product complaints program, ensuring timely evaluation, investigation, and closure of product quality complaints .

Posted 9/16/2026full-timeWest Chester • Ohio • United StatesSenior💰 $115,000 - $182,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expert knowledge of cGMP regulations and complaint management within the Pharma/Biotech industry, with a strong focus on leading cross-functional teams and ensuring compliance with quality standards. Proven ability to influence stakeholders and drive process improvements while managing complex investigations and complaint resolutions.

Highest-signal resume keywords

Expert Knowledge Of cGMPComplaint Management Program OwnershipCross-Functional Team LeadershipRegulatory Compliance ExperienceProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceRegulatory ComplianceTechnical WritingRoot Cause AnalysisComplaint InvestigationData AnalysisKPI DevelopmentProcess ImprovementSterile Product ManufacturingDeviation Management

Soft Skills

Influencing SkillsPeople LeadershipConflict ResolutionCommunication SkillsCoaching And Development

Certifications & Qualifications

CQACQECQM

Industry Keywords

PharmaBiotechFDA RegulationsEU RegulationsJP RegulationsICH GuidelinesISO GuidelinesQuality AgreementInspection ReadinessMulti-Site Quality Management

About the role

Key responsibilities & impact

Own the product complaints program, ensuring timely evaluation, investigation, and closure of product quality complaints
Set complaint intake, triage, categorization, criticality criteria, and turnaround expectations
Set investigation standards and approve conclusions on root cause, product impact, reportability, and CAPA initiation
Lead escalated, precedent-setting, or client-sensitive complaint cases
Ensure complaint handling complies with GMP, regulatory, company procedure, and Quality Agreement requirements
Prepare and present quarterly and annual complaint trend reports to site and global quality leadership
Serve as authoritative voice on complaint findings and outcomes to clients and regulatory agencies
Design and implement complaint-handling process improvements
Lead cross-functional teams across quality assurance, manufacturing, quality control, and client functions
Ensure complaint documentation is accurate, complete, and maintained; review and approve investigations, forms, SOPs, and work instructions
Define complaint-handling KPIs and performance targets, set team goals, and act on adverse trends
Represent the Product Complaints Program as subject-matter expert during FDA, regulatory, and client audits and inspections
Own complaint-related inspection readiness, document availability, inspection-room support, and staff preparation
Partner with operational and client-facing teams to secure resources and commitments for timely complaint closure
Set annual improvement goals and workstream priorities for the complaints program
Influence and educate operational and support areas on quality and compliance expectations
Lead, coach, and develop direct reports through goal setting, performance reviews, feedback, recognition, training, and qualification
Serve as site point of contact for the Product Complaints Program
Escalate site-specific complaint issues with recommended containment and corrective actions
Determine staffing, systems, and budget needs; negotiate timelines and resources with peer functional leaders

Requirements

What you’ll need

Expert knowledge of cGMP in the Pharma/Biotech industry, including FDA, EU, and JP regulatory requirements and ICH/ISO guidelines
Demonstrated ownership of a complaint, deviation, or investigation program, including accountability for program-level metrics, regulatory commitments, and Quality Agreement obligations
Knowledge of pharmaceutical and biotechnology processes, including sterile product manufacturing processes, inspection, packaging, labeling, and testing
Demonstrated ability to resolve investigations where root cause is contested or data is incomplete, and defend conclusions to regulators, clients, and senior leadership
Demonstrated ability to set direction for a team and cross-functional partners without direct authority, and prioritize competing workstreams across sites
People leadership experience, including hiring, goal setting, performance management, and development of technical staff
Strong project management and technical writing skills
Ability to influence others in sensitive or escalated situations, including client, regulatory, and senior leadership audiences
Bachelor’s degree in a science/technical field such as pharmacy, biology, chemistry, or engineering (preferred)
Advanced degree or MBA (preferred)
10+ years of experience in Quality Assurance / Regulatory Compliance within pharma/biotech, including ownership of a complaint, deviation, or investigation program and experience leading people or cross-functional project teams (preferred)
ASQ certifications such as CQA, CQE, and CQM (preferred)
Active membership in pharmaceutical trade associations such as ISPE or PDA (preferred)
Experience in a multi-site or global quality organization, including leading complaint or investigation workstreams across more than one site (preferred)
Sponsorship or support for work authorization, including visas, is not available

Benefits

Comp & perks

Annual cash bonus program
401(k) plan with a generous company match
Healthcare including medical, dental and vision
Family building benefits
Life and disability insurance
Paid vacation
Paid holidays
Other paid leaves of absence
Tuition reimbursement
Support for caregiving needs