hims-and-hers - Quality Complaint Specialist

Remote - UK3w ago

Remote Mid EMEA Pharmaceuticals Manufacturing Pharmacist Quality Control Inspector Reporting Regulatory Affairs Documentation Close

Requirements

• 3+ years 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. • Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. • It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. • Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. • To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement https://www.hims.com/global-candidate-privacy-statement.

Responsibilities

• Serve as the second point of intake for product-quality complaints relating to dispensed commercial medicines and non-sterile compounded (Article 10 "specials") preparations, logging each complaint accurately and promptly in the complaint management system. • Support the Superintendent Pharmacist in triaging incoming complaints to determine severity, patient safety impact, and whether escalation (e.g., potential recall, MHRA Yellow Card, or Defective Medicines Report Centre notification) is required. • Lead and/or support end-to-end complaint investigations, including root cause analysis, batch/lot traceability, retained sample review, where applicable, and liaison with the originating pharmaceutical supplier or wholesaler where the complaint concerns a commercially sourced product. • Support complaint investigations specific to non-sterile compounded preparations, ensuring alignment with MHRA guidance on unlicensed medicines ("specials"), Human Medicines Regulations 2012 (Article 10/Regulation 3, Schedule 1 exemptions), and applicable professional standards (GPhC, RPS non-sterile compounding guidance). • Draft clear, well-evidenced investigation reports and CAPA (Corrective and Preventive Action) plans, when applicable; track CAPAs to timely closure and verify effectiveness. • Maintain accurate, audit-ready documentation in line with Good Documentation Practice (GDP), including complaint files, correspondence with patients/prescribers/suppliers, and trending data. • Identify and report trends in complaint data to the Superintendent Pharmacist and Quality leadership, flagging recurring issues that may indicate a systemic quality or supply issue. • Support the Superintendent Pharmacist in maintaining the pharmacy's compliance with MHRA inspection readiness, GPhC standards for registered pharmacies, and relevant SOPs governing complaint handling, deviations, and non-conformances. • Assist with drafting, reviewing, and revising SOPs related to complaint handling, non-conformance management, and supplier quality as it relates to complaint handling for both the dispensing and compounding operations. • Liaise with pharmaceutical suppliers and wholesalers to ensure appropriate records are available as necessary to close out applicable complaint investigations, when necessary. • Support internal audits and MHRA/GPhC inspections by preparing complaint files, trend reports, and CAPA evidence. • Escalate any signal of a potential quality defect, adverse reaction, or patient safety risk to the Superintendent Pharmacist without delay.

Benefits

• The actual amount will take into account a range of factors that are considered in making compensation decisions, including but not limited to skill sets, experience and training, licensure and certifications, and location. H&H also offers a comprehensive Total Rewards package that may include an equity grant. • Consult with your Recruiter during any potential screening to determine a more targeted range based on location and job-related factors. • This job has application limits • To ensure that we can give proper consideration to everyone who's excited about joining Hims & Hers, we ask that you please only apply to a specific role once within a 60-day period. If you weren’t selected this time, you are welcome to check back and reapply after 60 days. • We truly appreciate your interest in Hims & Hers and look forward to staying connected! • Autofill from resume • Upload your resume here to autofill key application fields. • Drop your resume here! • Parsing your resume. Autofilling key fields... • Candidate Information • LinkedIn Profile URL • If you don't have a LinkedIn profile, please write NA • or drag and drop here • Have you previously worked for hims & hers as an employee or contractor/consultant? • This includes any subsidiary companies, including but not limited to Apostrophe or Honest Health. • Recruiting Privacy Policy • Submit Application • Hims & Hers may use Artificial Intelligence with this application. Learn more.