Senior Manager, Product Complaints (Biotech)

Location: West Chester, Ohio, USA; onsite role

Salary: $115,000–$182,500 per year

Company

Technology-focused biomanufacturing company building sustainable, end-to-end manufacturing solutions for medicines.

What you will do

• Own complaint intake, triage, categorization, investigation standards, timelines, and closure.
• Approve root-cause, product-impact, reportability, and CAPA decisions, and lead escalated or client-sensitive investigations.
• Analyze complaint trends and present recurring causes, emerging risks, and improvement actions to site and global quality leadership.
• Communicate complaint findings and outcomes to clients, FDA and other regulatory agencies, auditors, and senior leadership.
• Lead cross-functional teams across quality assurance, manufacturing, quality control, and client-facing functions.
• Define KPIs, improve complaint processes, maintain inspection readiness, and manage program resources and priorities.

Requirements

• Expert knowledge of cGMP in the pharmaceutical or biotechnology industry, including FDA, EU, and JP requirements and ICH/ISO guidelines.
• Experience owning a complaint, deviation, or investigation program with responsibility for metrics, regulatory commitments, and Quality Agreement obligations.
• Knowledge of sterile product manufacturing, inspection, packaging, labeling, and testing processes.
• Ability to resolve investigations with contested root causes or incomplete data and defend conclusions to regulators, clients, and senior leaders.
• Experience setting direction for teams and cross-functional partners, with strong project management and technical writing skills.
• People leadership experience, including hiring, performance management, staff development, and training.

Nice to have

• Bachelor’s degree in pharmacy, biology, chemistry, engineering, or another science or technical field.
• Advanced degree or MBA.
• 10+ years of Quality Assurance or Regulatory Compliance experience in pharma or biotech.
• ASQ certifications such as CQA, CQE, or CQM.
• Experience in a multi-site or global quality organization and membership in ISPE, PDA, or similar associations.

Culture & Benefits

• Full-time employment with an annual cash bonus program.
• 401(k) plan with a company match and healthcare coverage including medical, dental, and vision insurance.
• Paid vacation, holidays, and other paid leaves of absence.
• Family-building benefits, life and disability insurance, tuition reimbursement, and caregiving support.
• Visa and work authorization sponsorship are not available.