Combination Product Quality Specialist Consultant at PA Knowledge Limited - Denmark

Melbourn, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

21 Jul, 26

Salary

0.0

Posted On

22 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality assurance, Regulatory compliance, ISO 13485, 21 CFR Part 4, Risk management, ISO 14971, Combination products, Medical devices, Pharmaceuticals, Design history files, Technical documentation, Supplier qualification, Technology transfer, Post-market surveillance, Project management, Stakeholder engagement

Industry

Business Consulting and Services

Description

Company 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. Job Description 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. 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. Project delivery 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 We’re looking for someone who combines deep technical expertise with a consulting mindset. You’ll 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, 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. We know the skill-gap and ‘somewhat need to tick every box’ can get in the way of meeting brilliant candidates, so please don’t hesitate to apply – we’d 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 you're unsure about your eligibility, we encourage you to review the UK Government’s guidance on security vetting before applying. #LI-KP1 Additional Information Life At PA encompasses our peoples' experience at PA. It's 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 world’s most complex challenges. We're 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) 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 [email protected]

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Responsibilities

You will provide expert quality and regulatory guidance for the development and lifecycle management of complex combination products. This involves managing quality systems, technical documentation, and risk management activities while collaborating with cross-functional teams to ensure product safety and compliance.