Combination Product Quality Specialist Consultant

• 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 lifecycle management of combination products (drugdevice biologicdevice and advanced therapydevice).

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 postmarket. Working as part of multidisciplinary project teams you will bring deep technical expertise alongside strong collaboration and stakeholder engagement skills.

What youll do

Youll 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 devicedrug expertise

• Acting as a subject matter expert on drugdevice 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 realworld conditions.

Regulatory and technical strategy

• Interpreting and applying evolving global combination product regulations providing pragmatic guidance throughout development technical transfer commercialisation and postmarket 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 scaleup and commercial manufacturing environments.
• Contributing to process validation equipment qualification and technical knowledge transfer ensuring regulatory alignment throughout.

Risk and postmarket activities

• Leading risk management activities in line with ISO 14971 including hazard analysis risk evaluation and mitigation strategies.
• Supporting postmarket surveillance vigilance and complaints investigations ensuring robust CAPA and documentation.

Project delivery

• Working as part of or leading crossfunctional project teams managing quality deliverables tracking actions and supporting timely decisionmaking.

Qualifications :

What youll bring

Were looking for someone who combines deep technical expertise with a consulting mindset. Youll ideally 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 handson knowledge of quality systems and regulatory frameworks (ISOCFR Part 4 FDA EU MDR).
• Proven experience authoring and maintaining quality and technical documentation in regulated environments.
• A welldeveloped 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.

We know the skill-gap and somewhat need to tick every box can get in the way of meeting brilliant candidates so please dont hesitate to apply wed love to hear from you.

Apply today by completing our online application

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 youre unsure about your eligibility we encourage you to review the UK Governments guidance on security vetting before applying.

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Additional Information :

Life At PA encompasses our peoples experience at PA. Its about how we enrich peoples working lives by giving them access to unique people and growth opportunities and purpose led meaningful work. 

Our purpose guides how we work with our clients and our teams and support our communities to deliver insight and impact solving the worlds most complex challenges. Were focused on building a workplace that values human difference and diverse mindsets and a culture of inclusion and equality that unlocks the potential in our people so everyone can be their best self. 

Find out more about Life at PA here. 

We are dedicated to supporting the physical emotional social and financial well-being of our people. Check out some of our extensive 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) 

Were 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  

Remote Work :

No

Employment Type :

Full-time