Complaint Investigation Manager (Direct Hire)
Bensenville, IL (Moving to Melrose Park, Spring or Summer of 2021)
Job Requisition: 6325
Description of Complaint Investigation Manager:
Responsible for managing QA Complaint Specialists within the Quality Contract Manufacturing group. Will review complaints and perform comprehensive complaint investigations from pharmaceutical contract manufactures and internal global manufacturing facilities. Will identify and take appropriate actions to ensure overall compliance for products released to distribution. Review and access field alert relevance checks for both product complaints and file FARs, as needed. Maintain compliance of SOPs, cGMPs, DEA, and FDA regulations. Review and assemble Quality metrics. With management, make decisions with broad impact in terms of rejected batches, quarantined goods, and revised production or marketing schedules. This position reports directly to the Director, QA Contract Manufacturing and supervises Direct Reports. Position requires communication with personnel at multiple sites.
Responsibilities for Complaint Investigation Manager:
- Manages team of QA Complaint Specialists to review complaints and perform comprehensive complaint investigations.
- Performs and/or provide QA review and approval of pharmaceutical Contract Manufacturing related Deviations, Product Complaints, CAPAs, SOPs, Change Controls, training documentation, and protocols/reports. May author these as required. Ensures completeness, accuracy, and compliance of all documentation.
- Reviews Field Alert for all contract manufactured product complaints received from a third party and file Field Alert Report, as needed.
- Follows up to ensure corrective action is implemented. Initiates/supports management meetings/projects to facilitate timely product disposition.
- Review and Concur or Approve Field Alert Relevance checks for product complaints and Events, impacting product in the field for all USA sites, as well as Global sites that manufacture products distributed in the USA, against the requirements of 21CFR314.81 and internal procedures.
- Performs and oversees training of personnel. Effectively develops, counsels, supervises, and motivates staff. Writes and administers performance appraisals for department personnel.
- Assures standard operating procedures (SOPs) accurately define the steps necessary for tasks, etc. Writes, reviews, and updates SOPs, Mitigation Plans, and Action Plans.
- Performs monthly quality metric reporting and tracks Complaints and Action Plans to ensure compliance. Makes recommendations and helps implement improvements. Follows up on corrective actions with responsible manufacture.
- Addresses quality concerns and questions in timely manner. Contacts contract manufacturers for investigational support. Offers recommendations as required.
- Support internal audits and external regulatory agency audits, supports audit requirements as well as internal audit functions such as controlled substances housed at Bensenville Distribution Center.
- Maintains knowledge of current GMPs, CFRs, FDA Guidance Documents, and other regulatory guidelines.
- Supports or participates in quality projects and teams to implement quality systems and improvements to meet regulatory or company requirements.
Requirements for Complaint Investigation Manager:
- Bachelor’s Degree required, preferably in a scientific discipline.
- Five to 10 years experience in a pharmaceutical manufacturing environment with background in investigations and product quality complaints.
- 1+ years management experience with direct reports
- Prior technical report writing experience
- Knowledge of legal and regulatory requirements governing the manufacture of pharmaceutical products. Must be able to recognize, investigate and resolve discrepancies and deficiencies.
- Ability to comprehend scientific/technical descriptions of analytical specifications, methods, manufacturing controls, and processes.
- Experience with field alerts and field alert reports is highly perferred
- Must be able to manage time effectively in a fast-paced pharmaceutical environment.
- Must be able to effectively work cross-functionally with all levels of personnel
- Experience with Microsoft Office programs is required, experience with TrackWise, SAP, and Documentum is preferred.
- Experience working with contract manufactures a plus
*Must be authorized to work in the United States; the Company will not sponsor work visas or other employment authorization.