Combination Product Quality Specialist Consultant

Combination Product Quality Specialist Consultant

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.

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.

What you'll do

You'll apply your quality and regulatory expertise across a broad range of client engagements, including:

Quality assurance and compliance

• 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.

Combination product and device drug expertise

• 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.

Regulatory and technical strategy

• 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.

Technology transfer and lifecycle management

• 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.

Risk and post market activities

• 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.

Qualifications What you'll bring

• 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.

Benefits

• 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).

Please be aware that some of our UK roles at PA Consulting require a UK security clearance.

All PA people are required to undergo background checks and to achieve the Baseline Personnel Security Standard; however, some UK roles also require higher levels of National Security Vetting, where applicants must have at least 5 years of continuous residency in the UK.

We therefore ask that you only apply if you meet the residency requirements (i.e. you are a British citizen or have been resident in the UK for the past 5 years), as this is the prerequisite for a security clearance. If you're unsure about your eligibility, we encourage you to review the UK Government's guidance on security vetting before applying.

We're 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 underrepresented groups.

Adjustments or accommodations - Should you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us on .