Quality Specialist, Regulatory Compliance & Pharmacovigilance

RegaloRx is a provider of patient assistance services that is designed to improve access to certain donated medicines and devices in the United States and its territories. Patients with a valid prescription and who qualify for a manufacturer’s program will receive those products from a licensed pharmacy. RegaloRx is based in Lenexa, Kansas, and connects philanthropic manufacturers and their foundations with patients who qualify for their donated products.

Purpose

Working closely with Operations and Compliance leadership, this position plays a crucial role in ensuring the quality of work performed by RegaloRx associates meets regulatory requirements and aligns with client agreements. This position collaborates cross-functionally with internal and external stakeholders. High attention to detail and in-depth understanding of quality and pharmacovigilance processes will contribute to the success of RegaloRx’s clients, who are world-class pharmaceutical and biotech companies.

Responsibilities

• Monitor, reconcile, and audit all potential sources of safety and product complaint information including (but not limited to) recorded calls, claims, faxes, text messages, chat logs and other records for the presence of Adverse Events (AEs), Special Situation Events (SSEs)/Other Safety Findings (OSF), and/or Product Quality Complaint (PQCs).
• Ensure all reported AEs, SSEs/OSFs, and/or PQCs are identified, documented in the appropriate database, and reported within required timeframes as per client requirements and internal Company SOPs.
• Support internal CAPA program through documentation, investigation, tracking, trending, follow-up, and effectiveness monitoring of deviations. Provide support to internal functions to ensure robust CAPA investigation, root cause analysis, and plan.
• Perform and/or support periodic reconciliation, records inspection, internal audit activities, client audits, third party (vendor) audits, and regulatory inspections.
• Provide support in development and monitoring of QMS across the Company including analysis and trending of CAPAs, audit observations, continuous improvement projects, and Quality Council.
• Perform risk assessments to determine internal and third party audit schedules.
• Plan, schedule, perform, and report range of audits across internal operations, projects, clients, systems, suppliers, and Pharmacovigilance with minimal supervision.
• Perform and deliver high quality audits and corresponding reports within specified timelines.
• Collect and review responses to audit observations and follow-up. Escalate inadequate or delayed responses when required to ensure timelines are met and satisfactory responses are obtained.
• Host and support client and regulatory audits/inspections.
• Document and investigate Privacy (HIPAA) and other Company-related Compliance issues.

Qualifications

• Minimum B.A./B.S. in life/health sciences or related field.
• Minimum 2 years of pharmaceutical industry experience in Quality Assurance or similar role.
• Minimum 2 years’ experience within Pharmacovigilance, Product Complaints, and/or Contact Center Hub within the Pharmaceutical Industry (Preferred).
• Minimum 2 years’ experience in planning, conducting, and reporting of audits including internal, client, supplier, system, process, and PV audits. Preferred Quality Auditor Certification [i.e., American Society for Quality (ASQ) Certified Quality Auditor (CQA)].
• Proficient in the development and execution of quality management systems
• Working knowledge and experience with FDA Regulations including 21 CFR 314.80, 820, 211.198, and HIPAA.
• Ability to learn and successfully utilize Quality System software. Prefer
• Experience with Quality Assurance software systems
• Highly proficient in Microsoft Office suite
• Must utilize problem-solving skills to resolve concerns independently or escalate problems to appropriate leadership when assistance or clarification is needed.
• Ability to use time efficiently.
• Preferred experience in client management.
• Problem solving, results orientated, analytical and high level of attention to detail.
• Preferred Quality Assurance experience within IT and validation.
• Must have strong analytical, written & oral communication.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: Remote