Share Email Opening Title Complaints Manager - Pharma/Medical Device  About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.   Description GENERAL DESCRIPTION: Responsible for managing the product complaints and all related activities associated with the complaint handling program at kaléo per corporate procedure and regulatory standards. The scope of responsibility encompasses managing the complaint processes to comply with corporate procedures and FDA regulations per CFR Part 820, 211, 210 and ISO13485 and other regulatory requirements as applicable. Escalate and participate in resolution of potential product deficiencies for all applicable kaléo products. Ensure CMO and service provider procedures support kaléo's corporate policies and guidance while aligning with all of the necessary regulations and standards. Serves as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management and complaint handling processes for all applicable products. PRINCIPAL DUTIES AND RESPONSIBILITIES: Serve as point of contact for commercial product complaints and post market product vigilant monitoring process Receive, process, and initiate product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process. Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance. Assess product complaints for potential regulatory notification. Interface and collaborate with various departments, CMO, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc.) and vendors/contractors on product complaint issues. Conduct follow-up with reporters for additional information necessary to complete a detailed investigation. Arrange the return of complaint materials to appropriate departments for evaluation. Assure that all product complaints are investigated to the appropriate level within the required timeline. Critically review and approve all investigation conclusions. Provide response to product complaint reporters. Alert Quality Management of all potential regulatory notification, and escalate trends and product complaints that potentially require a regulatory action (e.g. recall, production hold, etc.). Perform analysis and trending of product complaints. Generate product complaint reports to identify and evaluate any trend signals observed and initiate investigations when required. Conduct periodic complaint review meetings. Represent kaleo as the Subject Matter Expert (SME) for the product complaints process. Interact with auditors and regulatory bodies to present the product complaint system during audits and inspections. Educate employees and contractors on the reporting of product complaints. Support the Annual Product Review process. Perform other duties as assigned.   Open Date 1/7/2018   Position Requirements POSITION REQUIREMENTS: Bachelor's degree with a minimum of 5 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing facility. Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products. Knowledge of US FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation. Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits. Good understanding of the manufacture of combination products and the linkage to customer complaints. Strong attention to detail, good organizational skills and well-structured. Has a systematic way of working, prioritizing tasks based on risk or criticality - seeking effective solutions within the complexity that surrounds product complaints. Excellent troubleshooting and problem-solving skills. Skill in writing investigation summaries and complaint responses. Independent, organized and able to schedule work without supervision to meet schedule deadlines. Ability to work independently as well be an effective team member and leader to others and CMO personnel. Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors.   Exempt/Non-Exempt Exempt   Full-Time/Part-Time   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Location Corporate   This position is currently not accepting applications. To search for an open position, please go to http://KaleoPharma.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found -- Follow us See who works here:

 

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