Quality Assurance Specialist

Job description

Job Description Make a real impact on patient safety and product quality. Join our Global Development Quality (GDQ) team in London as a QA Specialist, where you’ll play a key role in GMP Quality Assurance activities supporting our GDQ IMP Licence. You’ll partner across functions, shape quality standards, and help ensure our products meet the highest regulatory and ethical benchmarks. What you’ll do Lead and perform GMP audits to ensure compliance with SOPs, GMPs, and applicable regulations Review and approve production and analytical documentation for drug substance, drug product, and packaged finished goods, supporting QP certification Collaborate across functional teams to resolve comments and issues identified during audits and reviews Support product recalls and stock recoveries when required Identify compliance gaps and drive continuous improvement initiatives Create, update, and maintain assigned SOPs Perform and review complaints, deviation investigations, change controls, and CAPAs Contribute to onboarding and training of new starters and colleagues Follow standard procedures and consult with your manager to resolve exceptions Compile data for reports and presentations, interpret findings, and draw actionable conclusions Deliver work to high standards of compliance, efficiency, innovation, accuracy, and safety Stay current with cGMP requirements and evolving global regulations Represent GDQ on cross-functional teams and support additional activities as assigned What you’ll bring Bachelor’s degree in a life science or related discipline Applied professional experience in pharmaceutical Quality roles Strong, collaborative communication skills and a self-motivated mindset Demonstrated understanding of GMP and solid technical knowledge Proven ability to lead and contribute as a team player; capable of prioritising and delivering across multiple projects and tasks Advanced problem-solving and sound decision-making skills Proficiency with Microsoft applications and readiness to learn and use GMP-related software Why join us Be part of a mission-driven team ensuring products are safe, effective, and compliant Work in a collaborative environment with clear impact on regulatory success and patient outcomes Opportunities to grow your expertise across audits, quality systems, and cross-functional projects Ready to elevate quality with us? If this sounds like your next step, we’d love to hear from you. Closing date for applications: 05/06/2026 Required Skills: Auditing, Complaints Investigation, Compliance Reporting, Data Analysis, GMP Compliance, Good Manufacturing Practices (GMP), Investigation Management, Process Improvements, Quality Assurance (QA), Quality Control Management, Quality Management, Regulatory Compliance, Regulatory Requirements Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 08/6/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.