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Hims & Hers, a leading health and wellness platform and NYSE-traded public company, is seeking a Quality Complaint Specialist to support the UK Superintendent Pharmacist and Quality teams. This role is central to the pharmacy operation's compliance and patient safety, spanning two key areas: quality complaint management for commercially licensed medicines sourced from pharmaceutical wholesalers, and complaint investigation for non-sterile compounding (unlicensed "specials") pharmacy operations.
You will serve as the second point of intake for product-quality complaints, logging each complaint accurately in the complaint management system. You will support the Superintendent Pharmacist in triaging complaints to determine severity, patient safety impact, and escalation needs (e.g., potential recalls, MHRA Yellow Card notifications, or Defective Medicines Report Centre notification). You will lead and support end-to-end complaint investigations, including root cause analysis, batch/lot traceability, retained sample review, and liaison with pharmaceutical suppliers or wholesalers for commercially sourced products.
For non-sterile compounded preparations, you will support investigations ensuring alignment with MHRA guidance on unlicensed medicines, the Human Medicines Regulations 2012 (Article 10/Regulation 3, Schedule 1 exemptions), and professional standards (GPhC, RPS non-sterile compounding guidance). You will draft clear, well-evidenced investigation reports and CAPA (Corrective and Preventive Action) plans, tracking CAPAs to closure and verifying effectiveness.
You will maintain audit-ready documentation in line with Good Documentation Practice (GDP), identify and report trends in complaint data to leadership, and support the Superintendent Pharmacist in maintaining MHRA inspection readiness and GPhC compliance. You will assist with drafting and revising SOPs related to complaint handling and non-conformance management, liaise with pharmaceutical suppliers to close out investigations, and support internal and regulatory audits by preparing complaint files and trend reports. Any signal of a potential quality defect, adverse reaction, or patient safety risk must be escalated to the Superintendent Pharmacist without delay.
REQUIREMENTS:
- 3+ years of experience in a pharmacy, pharmaceutical quality, or regulatory affairs role within the UK, ideally within a dispensing pharmacy, wholesaler, or compounding/"specials" manufacturing environment
- Working knowledge of the Human Medicines Regulations 2012, including the Article 10 exemption framework for unlicensed "specials," and familiarity with MHRA guidance on complaint handling, recalls, and Defective Medicines Reporting
- Understanding of GPhC standards for registered pharmacies and pharmacy professionals, and experience supporting a Superintendent Pharmacist or Responsible Pharmacist in a regulated environment
- Familiarity with non-sterile compounding practices and associated quality/regulatory expectations (e.g., RPS professional guidance on unlicensed specials)
- Strong root cause analysis and CAPA experience; comfort applying structured investigation methodologies (e.g., 5 Whys, fishbone/Ishikawa)
- Excellent written communication skills, with the ability to produce clear, defensible investigation reports for regulators, auditors, and internal stakeholders
- High attention to detail and strong organisational skills, with the ability to manage multiple open investigations against defined timelines
- Experience with quality management systems (QMS) or complaint-tracking databases preferred
