Clinical Quality & Risk Manager

Category:  Clinical Development
Location: 

İstanbul, Marmara Region, TR

   

Shape the quality and integrity of clinical trials that bring life-changing therapies to millions of patients. As our new Clinical Quality & Risk Manager, you'll be the strategic force ensuring our clinical programmes meet the highest standards – safeguarding participant safety, protecting data integrity and driving continuous improvement across our Clinical Development Center.

 

Your new role

As Clinical Quality & Risk Manager (CQRM) within the Clinical Development Center (CDC), you will take a strategic lead in overseeing quality assurance and risk management activities for clinical trials. You'll ensure compliance with global regulations, ICH-GCP, international guidelines and Novo Nordisk policies – while identifying risks early, implementing mitigation strategies and championing a culture of quality by design.

 

Day-to-day, your tasks will include:

  • Enabling risk-based quality management by performing ongoing quality risk assessments at country level, developing actionable mitigation plans and using process analytics and digital tools to surface emerging risks
  • Driving strategic quality planning to align clinical quality goals with organisational objectives and regulatory standards, while leading adoption of local process changes
  • Providing data-driven productivity oversight – translating quality data into insights, conducting root cause analyses and supporting the implementation of CAPAs at local, regional and global levels
  • Engaging stakeholders and leading change management across cross-functional teams, and representing Novo Nordisk at external forums to influence local regulations
  • Ensuring quality oversight throughout the lifecycle of clinical programmes, including supporting CDC audits, Sponsor and site inspections, and acting as local point of contact for Health Authority inspections
  • Coordinating training by partnering with SMEs on local training release, championing centralised solutions and monitoring training compliance and effectiveness

You will work closely with trial squads, the Global Project Team, regional and HQ clinical teams, as well as external stakeholders including investigators, KOLs, Health Authorities, IRBs/Ethics Committees and patient advocacy organisations.

 

Your new department

In Product & Portfolio Strategy we drive commercial strategy, medical affairs and business development across all therapy areas. We act as a connector and compass, guiding the new Novo Nordisk portfolio for sustained competitiveness.

Within this area sits the Clinical Development Center (CDC) – the engine behind our clinical trial execution. Here, you'll join a team of dedicated professionals who combine scientific rigour, operational excellence and a relentless focus on quality to ensure that every trial we run meets the highest standards for patients, regulators and our own ambitions.

 

Your skills & qualifications

We're looking for a strategic and data-driven quality professional who thrives in a complex, regulated environment and enjoys collaborating across functions and geographies. You'll bring with you:

  • A Bachelor's degree in Life Sciences, Pharmacy or a related field (Master's degree preferred)
  • 5+ years of relevant experience in clinical operations or a quality role within the pharmaceutical industry or a CRO, ideally with a focus on risk-based quality and quality by design
  • Strong knowledge of GCP, clinical development and quality management systems, including proficiency in electronic QMS platforms, alongside a solid understanding of data integrity principles and emerging clinical trial technologies
  • Broad understanding of clinical R&D, global regulations and proven expertise in regulatory submission and inspection management, with demonstrated ability to ensure high-quality execution in compliance with ICH-GCP and internal SOPs
  • Strong project management skills – organisation, planning and prioritisation – combined with excellent interpersonal, negotiation and problem-solving abilities
  • Ability to communicate with clarity and impact to internal stakeholders, including senior management, and external stakeholders such as inspectors, at all organisational levels

 

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

 

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.