Combination Product Quality Specialist Consultant in Melbourn

Hybrid working – office or client site at least 2 days per week, up to 5 days on client site. The role can be based at either our London Victoria or Melbourn office. Within our Life Sciences practice, we support global organisations to design, develop and bring to market innovative products that improve patient outcomes. This role is a Combination Product Quality Specialist focused on drug-device, biologic-device and advanced therapy-device products.

What You’ll Do

• Quality assurance and compliance: Work within and advise on QMS compliant with ISO 13485, QMSR, 21 CFR Part 4 and other GxP. Author, review and maintain Design History Files, risk management files, technical documentation and change control records. Support supplier qualification, audits and gap assessments to meet global regulatory expectations.
• Combination product and device‑drug expertise: Act as subject matter expert on drug-device interactions and product integrity. Interpret and oversee Container Closure Integrity Testing (CCIT) for sterility and stability. Support design and evaluation of stability and compatibility studies for device and pharmaceutical components under real‑world conditions.
• Regulatory and technical strategy: Interpret and apply global combination product regulations, giving pragmatic guidance. Support preparation of regulatory submissions, technical dossiers and responses to authorities.
• Technology transfer and lifecycle management: Lead and support technology transfer activities across development, scale‑up and commercial manufacturing. Contribute to process validation, equipment qualification and technical knowledge transfer.
• Risk and post‑market activities: Lead risk management per ISO 14971. Support post-market surveillance, vigilance and complaints investigations and CAPA.
• Project delivery: Work as part of or lead cross‑functional project teams, manage quality deliverables, track actions and support decision‑making.

Qualifications

• Prior management consultancy experience is highly desirable.
• A degree in life sciences, pharmacy, engineering, or a related discipline.
• 8+ years of experience within combination products, pharmaceuticals, medical devices or biotechnology.
• Strong 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.
• 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.
• UK security clearance required; applicant must be a UK resident for at least 5 years.

Benefits

• Private healthcare and health & lifestyle perks.
• 25 days annual leave plus a bonus half day on Christmas Eve; option to buy 5 additional days.
• Generous company pension scheme.
• Annual performance‑based bonus and PA share ownership.
• Community and charity initiatives.
• Tax‑efficient benefits (cycle to work, give as you earn).

We are committed to advancing equality. We recruit, retain, reward and develop our people based solely on their abilities and contributions and without reference to their age, background, disability, genetic information, parental or family status, religion or belief, race, ethnicity, nationality, sex, sexual orientation, gender identity (or expression), political belief, veteran status, or any other range of human difference brought about by identity and experience. We welcome applications from under‑represented groups. Adjustments or accommodations – if you need any adjustments or accommodations to the recruitment process, please contact us at recruitmentenquiries@paconsulting.com.