Product Complaints Leader

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

Position Summary & Responsibilities

Product Complaints:

• Complaint Intake & Triage: Manages the process of receiving, logging, and categorizing incoming complaints.
• Investigation & Analysis: Oversees the investigation of complaints, ensuring thoroughness and accuracy, and analyzing data to identify trends and potential product issues.
• Compliance: Ensures all complaint handling activities comply with relevant regulations, company policies, and procedures.
• Communication & Reporting: Communicates investigation findings, both internally and externally, and prepares reports on complaint trends and performance.
• Process Improvement: Identifies opportunities to improve complaint handling processes and procedures and collaborates with other departments to implement solutions.
• Cross-functional Collaboration: Works with various departments (e.g., quality assurance, manufacturing, quality control) to resolve complaints and prevent future occurrences.
• Training & Mentorship: Provides guidance and training to team members on complaint handling procedures and best practices.
• Documentation: Ensures all complaint-related documentation is accurate, complete, and maintained according to regulatory requirements.
• Performance Monitoring: Track metrics related to complaint handling and takes corrective actions as needed.

Leadership:

• Build and maintain effective internal Resilience business relationships within operational and support units.
• Promote and encourage continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators and recognizing and rewarding high performance.
• Contribute to the training, education, guidance, and influencing of operational and support areas on quality and compliance policy and practices.
• Lead/drive improvements to quality compliance processes through cross functional project teams.
• Collaborate and influence key operations customers and stakeholders at all levels of the organization: globally and inside and outside of QA to deliver significant improvements in quality compliance.
• Coach and empower site colleagues to successfully execute the Product Complaints processes.
• Lead meetings maintaining agenda, minutes, active communication, and actions tracker.
• Serve as the site point of contact (SPOC) for the Product Complaints Program with site teams, global teams, and clients.
• Escalate and inform timely leadership and clients on the evaluation and management of site-specific escalations, as applicable.
• Provide reports on quality trends, observations, and suggestions to leadership and clients, as applicable.

Inspection Readiness:

• Participate in internal audits and external quality system inspections conducted by the FDA and other regulatory agency representatives including client quality audits.
• Provide active support to the Logistics Center or Inspection Room during an external audit/inspection.

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Minimum Requirements

• Strong knowledge of cGMP in the Pharma/Biotech/Chemical/Food & Beverage industry to include FDA, EU, JP regulatory requirements as well as ICH/ISO guidelines
• Experience in product complaint management, quality assurance, or a related field.
• Experience with complaint management systems and databases.
• Excellent investigational and QA problem solving skills
• Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams
• Strong leadership, project management, and technical writing
• Strong interpersonal, communication, and influencing skills

Preferred Background

• Bachelor's degree in a science/technical field such as pharmacy, biology, chemistry, or engineering
• Advanced degree or MBA is desirable
• Knowledge of pharmaceutical and biotechnology processes: aseptic and sterile product manufacturing processes, inspection, packaging, labelling, testing, etc.
• Extensive experience in QA/Regulatory Compliance in the pharmaceutical industry
• ASQ certifications (e.g., CQA, CQE, and CQM)
• Active member of pharmaceutical trade associations such as ISPE, PDA, etc.

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.