Senior Manager, Product Complaints

Resilience; Port Union (OH); On-site; USD 115,000 - 183,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Comprehensive healthcare benefits

Paid vacation and holidays

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a Senior Manager of Product Complaints to own the program, ensuring timely evaluation, investigation, and closure of product quality complaints in GMP and regulatory alignment. You’ll set goals, manage investigations with cross-functional teams, and advise leadership and clients on risk and remediation.

You will lead complaint handling staff, drive continuous improvement, and represent the site in regulatory inquiries, audits, and

Qualifications

• Expert knowledge of cGMP in pharma/biotech, including FDA/EU/ICH guidelines.
• Ownership of a complaint/investigation program with metrics and commitments.
• Knowledge of sterile product manufacturing, QA, and regulatory expectations.
• Ability to resolve investigations with contested data or incomplete data.
• Proven ability to lead a team and coordinate cross-functional partners.
• Strong project management and technical writing capabilities.
• Effective communication with regulators, clients, and leadership.

Responsibilities

• Own the intake, triage, and categorization of complaints with defined criteria.
• Lead investigations, approve conclusions on root cause and reportability; manage escalations.
• Ensure compliance with regulations and company procedures; timely delivery of duties.
• Prepare quarterly and annual complaint trend reports for leadership.
• Act as authoritative voice to clients and regulatory bodies on findings.
• Design improvements to complaint handling processes with other departments.
• Lead cross-functional teams to resolve complaints and prevent recurrences.
• Review/approve complaint investigations and related documentation.
• Define KPIs, set team goals, and monitor adverse trends.

Skills

cGMP knowledge

Regulatory compliance

Root cause analysis

Cross-functional collaboration

People leadership

Project management

Technical writing

Communication skills

Influence stakeholders

Quality systems

Education

Bachelor's degree in science/engineering

Advanced degree or MBA

ASQ certifications

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

The Senior Manager, Product Complaints owns the product complaints program to ensure timely evaluation, investigation, and closure of product quality complaints in compliance with GMP, regulatory, and company requirements. This role ensures that complaint trends are analyzed, escalated when applicable, and used to drive continuous improvement in product quality and patient safety. The role sets goals and priorities for the complaints program, manages the investigation and timelines required across Quality and the Investigation Team, and applies judgment on reportability and product-impact decisions that affect site operations and client commitments. The Senior Manager leads and develops complaint handling staff and influences site leadership, global quality, clients, and auditors on complaint-related risk and remediation decisions.

Job Responsibilities

Core Responsibilities

• Complaint Intake & Triage: Own the process of receiving, triaging, and categorizing complaints, setting criticality criteria and turnaround expectations, and ensuring consistent application of processes across complaints.
• Investigation & Analysis: Set investigation standards and approve conclusions on root cause, product impact, reportability, and CAPA initiation; personally lead escalated, precedent-setting, or client-sensitive cases.
• Compliance: Ensure all complaint handling activities comply with relevant regulations and company procedures. Accountable for the timely and compliant delivery of complaint responsibilities in accordance with Quality Agreement requirements.
• Trend Reporting: Prepare and present quarterly and annual complaint trend reports to site and global quality leadership, highlighting recurring root causes, emerging risk signals, and recommended actions to drive continuous improvement.
• Client & Regulatory Communication: Serve as the authoritative voice on complaint findings and outcomes to clients and regulatory agencies, including responses to client quality inquiries and regulatory requests.
• Process Improvement: Design and implement improvements to complaint handling processes, partnering with other departments to implement solutions.
• Cross-functional Collaboration: Lead cross-functional teams (e.g., quality assurance, manufacturing, quality control, clients) to resolve complaints and prevent future occurrences.
• Documentation: Ensure all complaint-related documentation is accurate, complete, and maintained according to regulatory requirements. Review and approve complaint investigations and complaint-related documentation (e.g., forms, SOPs, work instructions).
• Performance Monitoring: Define complaint handling KPIs and performance targets, set team goals against them, and act on adverse trends.

Inspection Readiness

• Represent the Product Complaints Program as subject-matter expert during internal audits and external inspections by the FDA and other regulatory agencies, including client quality audits, and own responses and commitments arising from complaint-related observations.
• Own complaint-related inspection readiness, including document availability, back-room support to the Logistics Center or Inspection Room, and preparation of staff called as subject-matter experts.

Leadership & Program Ownership

• Partner with Manufacturing, QC, QA, and client-facing teams to secure the resources and commitments needed to close complaints within required timelines.
• Set annual improvement goals for the complaints program and deliver them through team-based processes and key performance indicators.
• Influence and educate operational and support areas on quality and compliance policy, standards, and expectations.
• Lead, coach, and develop direct reports, including goal setting, periodic performance reviews, feedback, and recognition; ensure staff are trained and qualified on complaint handling procedures and best practices.
• Serve as the site point of contact (SPOC) for the Product Complaints Program with site teams, global teams, clients, and auditors.
• Escalate site-specific complaint issues to leadership and clients on a timely basis, including recommended containment and corrective actions.
• Determine staffing, systems, and budget needs for the complaints program, set annual workstream priorities for the team, and negotiate timelines and resources with peer functional leaders.

Education & Experience

Minimum Requirements

• Expert knowledge of cGMP in the Pharma/Biotech industry, including FDA, EU, and JP regulatory requirements and ICH/ISO guidelines, with the ability to interpret and apply them to novel or contested complaint scenarios where internal precedent does not exist.
• 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: sterile product manufacturing processes, inspection, packaging, labeling, testing, etc.
• Demonstrated ability to resolve investigations where root cause is contested or data is incomplete, and to defend conclusions to regulators, clients, and senior leadership.
• Demonstrated ability to set direction for a team and for cross-functional partners without direct authority, and to 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 change the thinking of others in sensitive or escalated situations, including client, regulatory, and senior leadership audiences.

Preferred Requirements

• Bachelor's degree in a science/technical field such as pharmacy, biology, chemistry, or engineering.
• Advanced degree or MBA.
• 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.
• ASQ certifications (e.g., CQA, CQE, and CQM).
• Active member of pharmaceutical trade associations such as ISPE, PDA, etc.
• Experience in a multi-site or global quality organization, including leading complaint or investigation workstreams across more than one site.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $115,000.00 - $182,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.