Clinical Quality Assurance, QA Senior Specialist – IVDs/Devices

Cpl Life Sciences
Manchester
5 days ago
Create job alert

Job Title:Clinical Quality Assurance, QA Senior Specialist – IVDs/Devices

Job Type:Full time, permanent position

Remuneration:Up to £41,000 OR €47,000 + 8% bonus + benefits

Location:Manchester, UK OR Barcelona, Spain (hybrid)


Position Description

An exciting new role has arisen within the Quality Assurance team. Based at either our Barcelona or Manchester sites, the successful candidate will take on responsibility for quality and compliance oversight of the activities performed by the Clinical Affairs team, in support of the testing and registration of diagnostic tests covering a diverse portfolio of indications. The scope of the trials is global and includes multi-centre trials managed out of several different locations.


Key responsibilities:

  • Work with members of the Clinical Affairs team to ensure compliance during trial activities – e.g. closure of deviations, complaints etc.
  • Represent Clinical QA as a member of project teams for planned and ongoing clinical trials, including Quality review of clinical relevant documentation
  • Support qualification and perform independent QA audits of clinical study sites
  • Participate in the internal audit program
  • Review Clinical Affairs SOPs


Position Requirements

  • Degree qualification in a relevant subject, or equivalent employment experience
  • Proven working experience as a Clinical Research Associate or similar with knowledge of relevant regulations, standards, guidelines and best practice
  • Desirable: working knowledge of In Vitro Diagnostic or Medical Device Regulations
  • Desirable: experience as an Auditor and/or Subject Matter Expert in regulatory inspections
  • Willingness and availability to travel internationally (Europe + USA) up to 10%
  • Ability to work independently while exercising good judgement and decision making within defined practices and policies
  • Excellent communication and interpersonal skills with the ability to work effectively with multinational/ cultural teams and individuals


For more information, please reach out me at

Related Jobs

View all jobs

Senior Quality Assurance Specialist

Principal Clinical Biochemist

Quality Assurance Officer - Global Pharma

Clinical Study Manager (m/f/d)

Principal Pharmacist Aseptic Quality and Stability (Hybrid)

Regional Sales Specialist

Get the latest insights and jobs direct. Sign up for our newsletter.

By subscribing you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Global vs. Local: Comparing the UK Biotech Job Market to International Landscapes

How to navigate opportunities, salaries, and work culture in biotechnology across the UK, the US, Europe, and Asia Biotechnology has steadily evolved from a specialised branch of life sciences to an influential force shaping healthcare, agriculture, environmental sustainability, and even digital technology through bioinformatics. From the development of groundbreaking gene therapies and vaccines to the engineering of sustainable biofuels and lab-grown foods, biotech has become one of the most innovative and impactful sectors worldwide. As such, the demand for skilled professionals—from research scientists to regulatory affairs experts—is on a steep upward trajectory. For job seekers looking to build or enhance their careers in biotechnology, understanding how different regional markets compare can be a game-changer. In this blog post, we examine how the UK biotech job market stacks up against that of the United States, Europe, and Asia. We’ll explore not only the scale of job demand and differences in salaries, but also important nuances around work culture and professional growth. For those considering remote or international positions, we’ll offer valuable insights to help you make informed decisions. Whether you’re a recent graduate from a life sciences programme, a seasoned researcher branching into industry, or a professional pivoting from a related discipline such as pharma or chemical engineering, the global biotech landscape is replete with opportunities. By assessing factors like salary expectations, cost of living, regulatory environments, and cultural norms, you’ll be better equipped to navigate the evolving biotech world—and thrive in a sector that’s reshaping our future.

Biotechnology Leadership for Managers: Strategies to Motivate, Mentor, and Set Realistic Goals in Research-Driven Teams

Biotechnology—spanning everything from gene editing to vaccine development—plays an increasingly pivotal role in shaping our global future. As breakthroughs in molecular biology, genomics, and bioinformatics cascade into real-world applications, the ability to lead high-performing biotech teams has never been more critical. Today’s biotech leaders must combine scientific literacy, strategic thinking, and people-focused management to drive innovation while meeting stringent regulatory and ethical standards. This article provides actionable insights into how biotech managers can motivate, mentor, and set achievable milestones for research-focused teams. Whether you are spearheading cutting-edge R&D, managing clinical trials, or overseeing large-scale production in a pharmaceutical environment, the strategies outlined here will help you foster a culture of innovation and excellence within your organisation.

10 Best Biotech Books for UK Job Seekers: Boost Your Biotechnology Career in 2025

The biotechnology industry is booming, fuelled by advancements in genomics, synthetic biology, regenerative medicine, and countless other cutting-edge fields. With the UK emerging as a major global biotech hub—spanning sectors like healthcare, agriculture, and environmental science—there has never been a better time to develop the skills and knowledge necessary to thrive in this dynamic sector. Whether you’re a recent graduate or a seasoned scientist, staying updated with the right resources can dramatically enhance your career prospects. In this blog post, we present ten must-read books that offer deep insights into the foundational concepts, practical techniques, and forward-thinking innovations shaping biotechnology today. By reading and internalising the wisdom of these texts, you’ll be better equipped to navigate job interviews, tackle complex projects, and excel in roles throughout the biotech landscape.