Director of Quality and Compliance

Job description


“Castor’s customers rely on us to provide them with a secure and compliant eClinical platform that enables them to adhere to regulatory requirements. We integrate quality and compliance into everything we do and are now hiring a Director of Quality & Compliance to ensure our quality system keeps pace with where the company is moving: biotech and pharma.” -
  Rob Konterman, COO


Who is Castor?

Castor is a leading cloud-based clinical data platform working with some of the world’s largest medical device companies, biopharmas and renowned academic institutes.


We simplify the clinical trial process, from recruitment to analysis, with user-friendly, patient centric technology. Our mission is to bring medical research into the digital age. Why? Because medical research is still largely run using free-text, paper and legacy technology.


Our self-service platform enables our users to run remote, device enabled, patient centric trials. By helping our users capture high quality data and making it machine readable, we are fundamentally changing the flawed evidence-based medicine process.

How is Castor supporting the Coronavirus crisis?

Castor has joined the global fight against the Coronavirus by making our research data capture system available for free for all COVID-19 research projects. As of July 01st, Castor is supporting more than 200 COVID-19 studies across the world.


What you’ll do

From maintaining a ‘world-class’ Quality & Information Security Management system (QISMS) to supporting commercial growth through compliance documentation, you’ll proactively lead, manage and enhance quality and compliance as we enter new, more regulated markets. You’ll also:


  • Manage supplier selection procedures and ensure quality of procurement
  • Maintain lean and practical policies and processes which reduce bureaucracy as we scale
  • Ensure fit-for-purpose product compliance and quality with clinical regulations and standards
  • Host customer audits and support in answering customer queries (including RFPs)
  • Inform on business strategy and product roadmapping with up-to-date compliance knowledge


What you’ll bring

With broad experience and knowledge across compliance and quality in the life sciences space, you’ll join and manage our in-house, ISO27001/ISO9001 specialized Quality Manager, working in a ‘hands-on’ role whilst also bringing the strategic qualities to advize, challenge and inform leadership. You’ll also have:

  • Strong knowledge of regulations such as GCP, 21 CFR Part 11, Annex 11 and HIPAA
  • Experience in computer systems validation and quality assurance
  • The ability to work with and implement compliance tooling such as QMS & audit systems
  • A self starter mentality with the adaptability and flexibility to work in a startup environment


What you’ll learn

It’s a crucial time for Castor. We’re on ‘full power mode’ and scaling-up at an exponential rate. For you, the opportunities are endless:


  • To support compliance and quality for a fast-growing startup in a highly regulated environment
  • Build out the compliance function in a start-up that is changing the way medical research is done
  • Collaborate with an entrepreneurial team, passionate to help customers achieve their goals
  • Be involved in maximizing the impact of medical research and improving healthcare


What you'll get

For Castor, we believe anything can be achieved with a healthy and happy team. We want to offer you some awesome benefits and the flexibility to truly succeed in your role:


  • A flexible and partly-remote working opportunity
  • A competitive salary and a guaranteed 'happy holidays' bonus
  • Investing in our talent with a strong Employee Stock Option Plan
  • 30 days annual leave (plus national holidays)
  • Interested in ‘lifelong learning’? You’ll love using our development and training budget!
  • We love good food! So, we provide lunch and healthy snacks in the office
  • Flexible approach to working - nobody is tracking your time except you
  • A new MacBook or Dell laptop
  • Like to feel zen? You’ll love our company subscription to Calm for meditation and yoga

      Requirements

      Want to know more? Check out the role profile for some further insights or apply now!