Manager/Senior Manager, GCP Quality

2 months ago


København, Denmark Ascendis Pharma AS Full time

Join the GCP Quality team in a leading and fast-growing biotech company.

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

Ascendis Pharma is currently expanding its GCP and GVP Quality with a quality and compliance position.

In GCP Quality you will together with a growing & dynamic quality team take part in the oversight of the compliance, quality, standards and training for Clinical Development and Development Operations areas. You will maintain an up-to-date knowledge of external requirements and ensure implementation of these in internal corporate procedures. You will as quality assurance partner advise and support the Global Development and Development Operations to ensure compliance and continuous process optimization.

You will join a dedicated GCP team located in Hellerup, Denmark and Palo Alto, USA. This role is based in Hellerup, Denmark and reports directly to the Vice President, GCP and GVP Quality, based in Denmark (Hellerup).

Main areas of responsibility:

  1. Collaborate with internal and external stakeholders to ensure appropriate GCP processes are implemented and maintained.
  2. Provide day-to-day expert quality & compliance advice on GCP processes to clinical teams.
  3. Lead subject matter experts in the maintenance of current SOPs and in the initiation and development of new procedures.
  4. Author and maintain SOPs owned by GCP Quality.
  5. Support Regulatory intelligence monitoring, assess impact and support implementation of new/updated GCP requirements on current practices and processes with relevant functions.
  6. Participate in the planning, conduct and follow-up on regulatory inspections.
  7. Collaborate with subject matter experts to formulate responses to audit/inspection findings relevant to GCP.
  8. Support quality development activities within the Quality Management System.
  9. Perform expert consultation on complex aspects of GCP to projects teams and department.
  10. Perform the role of quality partner to assigned departments & project teams.
  11. Monitor Quality systems to proactively identify risk.
  12. Support our Clinical trial supply team with IRT design and operation.

Criteria of success in the role will be a proven ability to take responsibility and drive compliance initiatives to meet the ever-growing and changing stringent global GCP requirements. Furthermore, a strong quality mindset and attention to detail in establishing priorities, scheduling, and meeting deadlines.

You hold a master’s degree in a scientific discipline and have a minimum of 5 years of relevant experience in the pharmaceutical industry with significant experience in GCP from clinical quality & compliance. You have extensive experience in quality systems, compliance monitoring, and the development and maintenance of SOPs and training programs. Experience with computerized systems within GCP regulated areas and medical device experience would be an advantage.

You are proficient in English at a professional level, both written and spoken.

You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You value inter-departmental team relationships using your excellent interpersonal, communication, analytical, and organizational skills. As Ascendis Pharma is an international biopharmaceutical company, it is important that you are flexible to have overlap of work hours with our colleagues based in the United States.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.

Travelling: 20-30 days per year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.

For more details about the job or the company, please contact: Louise Moe Engström, VP, GCP and GVP Quality on All applications must be submitted in English and are treated confidentially.

Application will be evaluated when received, so please apply as soon as possible.

#J-18808-Ljbffr

  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...

  • Senior Test Manager

    2 months ago


    København, Denmark Cognizant Full time

    Senior Test Manager Permanent Employment – Copenhagen What makes Cognizant a unique place to work? The combination of rapid growth and an international and innovative environment! This is creating a lot of opportunities for people like YOU — people with an entrepreneurial spirit who want to make a difference in this world. At Cognizant, together with...


  • København, Denmark Gtt Communications Denmark ApS Full time

    Role Summary The Project Management team is responsible for delivering paid-for projects to a high standard, ensuring that GTT recognises the associated revenue in a reliable and predictable manner and that the client experience is excellent, leading to those clients acting as references regarding the ability for GTT to deliver on its promises. The Project...


  • København, Denmark Carlsberg Danmark Full time

    Senior Manager Investigations Integrity, responsibility, honesty and ethical business conduct are core values of the Carlsberg Group. Our employees represent our brands worldwide and their individual actions can have an enormous impact on our reputation as a global business leader. The Group is committed to conducting business in a fair, responsible manner...


  • København, Denmark Carlsberg Group Full time

    Location: Copenhagen, DK Entity / company: Central Office Senior Manager Investigations Integrity, responsibility, honesty and ethical business conduct are core values of the Carlsberg Group. Our employees represent our brands worldwide and their individual actions can have an enormous impact on our reputation as a global business leader. The Group is...

  • Management Consultant

    2 months ago


    København, Denmark Efficio Limited Full time

    At Efficio, we're not just a consulting firm; we're a team of dedicated experts committed to transforming procurement and supply chain functions. Our mission is to drive sustainable, measurable value for our clients through innovative solutions and deep industry insights. Join us and be part of a dynamic environment where your skills and ideas make a real...

  • Senior Project Manager

    2 months ago


    København, Denmark GE Full time

    Job Description Summary Grid Solutions, part of GE Renewable Energy, is serving customers globally with over 20,000 employees in approximately 80 countries. Grid Solutions helps enable utilities and industry to effectively manage electricity from the point of generation to the point of consumption, helping to maximize the reliability, efficiency, and...


  • København, Denmark Radiometer Danmark Danaher Full time

    In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating...


  • København, Denmark Lundbeck AS, H Full time

    Press Tab to Move to Skip to Content Link Training manager, IT Quality & Compliance Requistion ID:  5574 Location:  Copenhagen, Danish Capital Region, DK Training manager, IT Quality & Compliance  Are you a visionary Training Manager with an enthusiasm for innovation and do you want to revolutionize how training is conducted? We are...

  • Senior Manager, Growth

    2 months ago


    København, Denmark HelloFresh Full time

    JOB DESCRIPTION The Role We are looking for a highly resourceful, entrepreneurial, and motivated Senior Manager, Growth to spearhead the launch of our newest brand in Denmark: Factor, a healthy, ready-to-eat meal subscription service.  As the Senior Growth Manager for Factor, you will be accountable for the entire marketing performance for Factor in...

  • Senior Manager, Growth

    2 months ago


    København, Denmark HelloFresh Full time

    JOB DESCRIPTION The Role We are looking for a highly resourceful, entrepreneurial, and motivated Senior Manager, Growth to spearhead the launch of our newest brand in Sweden: Factor, a healthy, ready-to-eat meal subscription service.  As the Senior Growth Manager for Factor, you will be accountable for the entire marketing performance for Factor in...

  • Senior Project Manager

    2 months ago


    København, Denmark Ramboll Group Full time

    Job Description Do you want to be at the heart of the energy transition industry, guiding the public and private sector in the delivery of technologies and systems to meet global and national net zero targets? Are you looking to bring your expertise and enthusiasm into play in developing a global, high performing design group delivering a range of innovative...


  • København, Denmark H. Lundbeck AS Full time

    Are you a visionary Training Manager with an enthusiasm for innovation and do you want to revolutionize how training is conducted? We are looking for someone who thinks beyond the standard of SOPs and can infuse creativity into both GXP and non-GXP training programs for our colleagues consisting of specialists within their field. If you’re ready to...


  • København, Denmark Ramboll Group Full time

    Job Description Do you want to be at the heart of the energy transition industry, guiding the public and private sector in the delivery of technologies and systems to meet global and national net zero targets? Are you looking to bring your expertise and enthusiasm into play in leading a global, high performing projects team delivering a range of innovative...

  • Senior Accountant

    2 months ago


    København, Denmark AMADA Senior Care Mesa Full time

    twentyAI is supporting a corporate management firm that provides comprehensive services to local and international businesses operating in Scandinavia. Their offerings include company formation, directorship, payroll, bookkeeping, tax compliance, and legal support. They serve a diverse range of clients. Established in 2014, the business has expanded its...


  • København, Denmark Globalconnect Full time

    Senior Product Manager - Security Solutions - Sweden Senior Product Manager - Security Solutions Are you passionate about connecting people and leading product development by having ownership of your own products, ensuring the development of Security solutions and innovation? Do you thrive on the challenge of translating complex technological concepts into...


  • København, Denmark zeroG - AI in Aviation Full time

    Are you looking for a global adventure in helping companies perform at their best? Are you motivated by innovation? Are you keen to understand and optimize the underlying processes and systems that make the world's best companies run? If so, Westernacher has the career as a Senior SAP Project Manager for you! Your responsibilities: Develop and maintain IT...


  • København, Denmark Ramboll Group Full time

    Job Description Do you want to be at the heart of the energy transition industry, helping to guide the public and private sectors in the delivery of technologies and systems to meet global and national net zero targets? Are you looking to bring your expertise and enthusiasm into play in developing a global, high performing project management group delivering...


  • København, Denmark Lundbeck AS, H Full time

    Senior Category Manager, Corporate Procurement Are you a purpose-driven procurement expert motivated by making business impact? Do you excel at collaborating with business and suppliers from all ends of the world? Then you might be our new Senior Category Manager for Packaging. Your new role In the role of Senior Category Manager, you will take global...

  • Senior Product Manager

    2 months ago


    København, Denmark Globalconnect Full time

    Senior Product Manager - Security Solutions - Norway Senior Product Manager - Security Solutions Are you passionate about connecting people and leading product development by having ownership of your own products, ensuring the development of Security solutions and innovation? Do you thrive on the challenge of translating complex technological concepts into...