Description
Are you passionate about Patient Safety? Do you have experience within Complaint Handling?If so, now is your chance to join Ascendis Pharma as our new QA Manager.Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.Today, we are advancing programs in Endocrinology Rare Disease and Oncology.
In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.We are seeking a passionate QA Professional/Associate to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in complaint management and handle complaint processes regarding both marketed products as well as products in Clinical Development. You will work globally and have wide collaboration across the organization and towards CMOs. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.You will be joining the Complaint Management team consisting of 5 colleagues, and report directly to Karina Bergenholtz, Director QAwho is based in Hellerup.You will be based in Helleup.
Your key responsibilities will be:
- Complaint management, incl. support, coordination and contact to stakeholders
- Drive quality improvement initiatives across the organization
Qualifications and Skills:
You have minimum 2-5 years of experience within the life science industry and experience working with GMP regulations. Preferably, you have experience with complaint processing of either drugs, medical devices and/or drug-device combination products. Furthermore, with a good business understanding, you thrive in a dynamic environment with many exciting and varied work tasks. To succeed in this role, an educational background in Natural Science on bachelor level or similar is required. You are proficient in English at a professional level, both written and spoken, and you master MS Office.
On a personal level, you are a highly motivated and self-driven individual who enjoys being challenged and working in collaborative environments. With your structured style of working, you are positive, and service minded. Moreover, you are pragmatic with an open and communicative approach and is thus inspired to find new and smart ways to fulfil quality requirements.
Key competencies:
You are a strong team player, analytical, and have a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
Apply now.
Applications will be evaluated when received, so please apply as soon as possible.All applications must be submitted in English and are treated confidentially.For more details about the position or the company, please contact Karina Bergenholtz, Director QA kab@ascendispharma.com or visit out website www.ascendispharma.com
Life at Ascendis Pharma
Thrive Here & What We ValueCollaborative work environment | Opportunities for professional growth and development | Flexible work schedule options | Recognition for outstanding performance</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient's lives | Guided by core values of Patients, Science, and Passion | Use TransCon® drug development platform to fulfill mission of developing new therapies | Advancing programs in Endocrinology Rare Disease and Oncology | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets | Seeking passionate People Leader to join growing function | Part of People Leader community with three People Leaders based in Hellerup and Princeton, US | Responsible for well-being and personal development of team members in Denmark | Work closely with Lene Rhein Larsen, People Leader, to continuously improve governance and people processes | Report to Lars Tranberg Pettersson, CIO and work out of our Hellerup office.</s> | Dynamic Workplace for Employees to Grow and Develop Their Skills | TransCon® Drug Development Platform to Fulfill Mission of Developing New and Potentially Best-in-class Therapies to Address Unmet Medical Needs | Exceptional Science, Visionary Leadership, and Skilled and Passionate Colleagues | Collaborative Environment for Skilled, Adaptable, and Highly Resourceful Professionals to Make Their Mark</s> | 1. Entrepreneurial and international company | 2. Short line of command | 3. GCP & GVP regulated environment | 4. Exciting product pipeline | 5. Highly skilled and experienced colleagues</s> | Collaborative culture on an accountability-based team | Unique offerings of Pet Insurance and Legal Insurance | Employee Assistance Program | Employee Discounts | Professional Development | Health Saving Account (HSA) | Flexible Spending Accounts | Various incentive compensation plans | Accident, Critical Illness, and Hospital Indemnity Insurance | Mental Health resources | Paid leave benefits for new parents</s> | 1. Guided by our core values of Patients, Science, and Passion | 2. Use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate bestin-class potential to address unmet medical needs. | 3. Advancing programs in Endocrinology Rare Disease and Oncology. | 4. Collaborating with partners around the world on the development of TransConbased products for other therapeutic areas and markets.</s> | 1. PatientCentric Approach | 2. ScienceDriven Innovation | 3. Passionate Team Members | 4. Collaborative Environment | 5. Dynamic Role</s> | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets</s> | Fast-paced environment with cross-functional, global teams | Collaborative, international and informal environment where we challenge and learn from each other</s> | Patient-centric, science-based, performance-driven | Creating an outstanding workplace</s> | Patient-centric approach to drug development | Emphasis on innovation and scientific excellence | Collaborative work environment with opportunities for professional growth | Focus on making a meaningful difference for patients through our innovative TransCon technology platform | Strong commitment to employee well-being and work-life balance</s> | Visionary leadership</s> | Fostering a place where skilled, adaptable, and highly resourceful professionals can truly make their mark | Using TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs | Advancing programs in Endocrinology Rare Disease and Oncology</s> | Dynamic, fast-growing global biopharmaceutical company | Onsite presence in our Palo Alto, CA office 3 times per week or more, as necessary | Travel within the US &/or to our corporate headquarters in Denmark may be necessary | Focuses on exceptional science, visionary leadership, and skilled and passionate colleagues. | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs. | Fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. | Offers dynamic workplace for employees to grow and develop their skills.</s> | Culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.</s> | Dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States | Providing strategic leadership to ensure the successful design and execution of non-clinical and clinical trials as well as Life Cycle Management Strategies | Engaging closely with internal peers and externally stakeholders such as the FDA, EMA, and other key regulatory bodies | Formulating strategies, enhancing performance, implementing relevant policies, and providing key insights that enable the organization to operate collaboratively and proactively.</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France | Applying innovative TransCon technology platform to build a leading, fully integrated biopharmaceutical company | Diverse pipeline designed to make a meaningful difference for patients | Started launching Endocrinology Rare Disease portfolio globally, in the US, Germany & Austria, with plans for rapid expansion</s> | Passionate about patients and science | Collaborative mindset | Diverse workforce offers a more personal understanding of our customers' needs and concerns | Trusting and appreciative company culture | Value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, and a dynamic, open, and informal working atmosphere | Tremendous opportunity to make an impact | Great team and corporate events | Attractive base salary, sponsored pension scheme (bAV), paid internet, exciting short- and long-term incentives | Structured onboarding program | Tailor-made training and development opportunities embedded in a well-resourced training budget | Direct connection to tram station, parking lots for cars and bikes | Soft drinks and wide variety of snacks | State-of-the-art workplace with iPhone, iPad, and brand-new laptop.</s> | Unique Ascendis DNA: flat hierarchies, short lines of communication, dynamic working atmosphere, tremendous opportunity to make an impact, great team and corporate events | Structured onboarding program, tailor-made training and development opportunities embedded in a well-resourced training budget | State-of-the-art workplace with iPhone, iPad, and brand-new laptop</s> | Collaborating with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Passionate about training and development — and ready to build something from the ground up | Patients, Science, and Passion core values | Adaptable and highly resourceful professionals can truly make their mark</s> | Fast-paced, cross-functional environment where your coordination skills drive real impact | Innovative treatments for rare diseases while growing commercial experience | Commitment to making a meaningful difference in patient’s lives | Use TransCon® drug development platform to fulfill mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives | Collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.</s> | Collaboration with cross-functional, global teams working together to achieve extraordinary results | Informal, open environment where innovation and change are key</s> | Collaborating with cross-functional, global teams working together to achieve extraordinary results | Entrepreneurial, informal, and open environment where innovation and change are key | Passionate about helping Commercial organizations gaining full value of their applications | Committed to making a meaningful difference in patients’ lives</s> | Collaborates with cross-functional scientific affairs team members to ensure that scientific standards are aligned across the organization | Stays current with industry trends, disease state areas, and treatment guidelines that impact training content | Offers employee discounts and mental health resources | Provides paid leave benefits for new parents</s> | Commitment to making a meaningful difference in patient's lives | Key strategic endeavour by Ascendis to expand global footprint in partnership with indirect affiliates across the globe</s> | Collaborating with cross-functional partners to identify and respond to local opportunities and customer needs</s> | Uses TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs | Commitment to advancing our Medical Affair’s teams’ scientific knowledge and skills, while making a significant impact in the lives of our patients</s> | Dynamic environment | Opportunity to develop skills and knowledge within the team | Flexible working hours to accommodate study and work</s> | Use TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | Diverse pipeline designed to make a meaningful difference for patients</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patients' lives | Exceptional science, visionary leadership, and skilled and passionate colleagues</s> | Fast-growing biopharmaceutical company with locations in Denmark, United States, Germany, United Kingdom, Italy, Spain, and France</s> | TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies</s> | Collaborative environment with strong relationships between internal team and external partners | Inclusive environment for all employees</s> | Purpose with impact – Your insights directly expand access to life-changing therapies. | Modern data stack – Green-field cloud platform, strong executive sponsorship and budget to innovate. | Global reach – Collaborate with colleagues in Copenhagen and Princeton. | Flexibility & growth – Hybrid work, generous benefits and clear paths to leadership or specialist roles. |user| | Mission that matters – Our pipelines accelerate insight generation that expands patient access to vital therapies. | Modern stack – Azure, Databricks, dbt, GitHub Actions – with room to propose new tools. | End-to-end ownership – Influence everything from ingestion to visualisation in a small, empowered team. | Hybrid flexibility & growth – Work three days onsite, enjoy generous benefits, great snacks and pursue clear technical or leadership paths.</s> | Core values of Patients, Science, and Passion. | TransCon® drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs.</s> | Using TransCon drug development platform to fulfill mission of developing new and potentially best-in-class therapies to address unmet medical needs</s> | 1. Fastpaced environment | 2. Collaborative work environment | 3. Open and informal culture | 4. Innovation and change are key</s> | Unique Ascendis DNA: Flat hierarchies, short lines of communication and a dynamic, open and informal working atmosphere. | Tremendous opportunity to make an impact. Great team and corporate events. | Attractive base salary, a sponsored pension scheme (bAV), we will pay for your internet, and we offer exciting short- and long-term incentives. | Structured, well-proven onboarding program to give you a clear picture of your responsibilities and the company you will be working for. | Direct connection to tram station, parking lots for cars and bikes. | Soft drinks and a wide variety of snacks. | State of the art: Your new workplace is waiting for you, including an iPhone, an iPad and a brand-new laptop.</s> | 1. HomeOffice Flexibility | 2. Attractive Compensation Package | 3. Continuous Learning Opportunities | 4. Regular Feedback Meetings | 5. Flexible Working Model</s> | Unique offerings such as Pet Insurance and Legal Insurance | 1. Fastgrowing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. | 2. Guided by core values of Patients, Science, and Passion. | 3. Collaborates with partners around the world on the development of TransConbased products for other therapeutic areas and markets.</s> | Fast-growing global biopharmaceutical company committed to making a meaningful difference in patient's lives.
