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Combination Product Quality Specialist Consultant

United Kingdom, Melbourn Employment contract · Job Posted April 24, 2026
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Job Description

We believe in the power of ingenuity to build a positive human future. As strategies, technologies, and innovation collide, we create opportunity from complexity. Our teams of interdisciplinary experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results. We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport. Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands. PA. Bringing Ingenuity to Life. Hybrid working - our approach is to be in the office or on client site a minimum of 2 days per week. However, the actual time you spend and where you spend it will vary by role or assignment, including up to 5 days per week on a client site. This role can be based at either our London Victoria or Melbourn office. Within our Life Sciences work, we support global organisations to design, develop and bring to market innovative products that improve patient outcomes. This includes complex combination products across pharmaceuticals, medical devices, biologics and advanced therapies. We are seeking an experienced Combination Product Quality Specialist to support the development and life‑cycle management of combination products (drug–device, biologic–device and advanced therapy–device). You will play a pivotal role in helping our clients navigate regulatory complexity, embed robust quality systems, and ensure product safety, compliance and performance from early development through to post‑market. Working as part of multi‑disciplinary project teams, you will bring deep technical expertise alongside strong collaboration and stakeholder engagement skills.

Job Responsibility

  • Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
  • Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records, ensuring alignment and traceability across the product life cycle
  • Supporting supplier qualification, audits and gap assessments, ensuring compliance with global regulatory expectations
  • Acting as a subject matter expert on drug‑device interactions and product integrity considerations
  • Interpreting and overseeing Container Closure Integrity Testing (CCIT) to support sterility and product stability
  • Supporting the design and evaluation of stability and compatibility studies, considering both device and pharmaceutical components under real‑world conditions
  • Interpreting and applying evolving global combination product regulations, providing pragmatic guidance throughout development, technical transfer, commercialisation and post‑market phases
  • Supporting the preparation of regulatory submissions, technical dossiers and responses to questions from competent authorities and notified bodies
  • Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
  • Contributing to process validation, equipment qualification and technical knowledge transfer, ensuring regulatory alignment throughout
  • Leading risk management activities in line with ISO 14971, including hazard analysis, risk evaluation and mitigation strategies
  • Supporting post‑market surveillance, vigilance and complaints investigations, ensuring robust CAPA and documentation
  • Working as part of, or leading, cross‑functional project teams, managing quality deliverables, tracking actions and supporting timely decision‑making

Requirements

  • Prior management consultancy experience is highly desirable
  • A degree in life sciences, pharmacy, engineering, or a related discipline
  • Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
  • Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
  • Proven experience authoring and maintaining quality and technical documentation in regulated environments
  • A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
  • Experience with supplier quality, audits, CAPA and document control
  • Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders

What we offer

  • Health and lifestyle perks accompanying private healthcare
  • 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
  • Generous company pension scheme
  • Opportunity to get involved with community and charity‑based initiatives
  • Annual performance‑based bonus
  • PA share ownership
  • Tax efficient benefits (cycle to work, give as you earn)

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