- Ensure quality oversight of stakeholders and support business functions and external service providers in quality matters related to transport and storage of Ascendis Pharma's drug substances, drug products and finish goods.
- Evaluation and approval of activities related to qualification/validation of transport and storage.
- Evaluation and approval of distribution related deviations, CAPAs and change controls
- Qualification of customers
- Participate and/or perform audits of external suppliers (transport companies and warehouses)
- Provide QA support to global launch activities and lifecycle management
- Initiate and cultivate strong, long-term relationships with key partners based on effective communication and collaboration.
- Provide regular updates to internal stakeholders on the status and success of partnerships.
- Establish processes and/or procedures for the partner collaboration, for i.e., sharing of documents, timely notifications, commitments and for other regulatory obligations, etc.
- Solid experience within QA and GDP regulated areas.
- Strong interpersonal and relationship-building skills.
- Excellent communication and negotiation abilities.
- Analytical mindset with the ability to assess and measure partnership performance.
- Ability to work independently and collaboratively in a fast-paced environment.
- Familiarity with pharmaceutical trends and dynamics.
- You are proficient in English at a professional level, both written and spoken.
- A team player with collaborative mindset building positive relationships and collaborating with others.
- Efficiently organizing and prioritizing tasks to meet deadlines and manage workloads effectively.
- Flexible and agile with the ability to quickly change direction and adapt to new priorities in a highly dynamic work environment.
- Result-oriented while still maintaining open-minded and looking for improved ways of working.
- Keeping the needs and satisfaction of partners and internal stakeholders in mind.
- You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
- Laptop, iPhone, paid internet, and home office equipment.
- A thorough and structured onboarding program.
- To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.
- Soft drinks, fresh fruit, and a wide variety of snacks every day, no strings attached.
- To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we will find a way to help you grow.
-
Student Assistants for Application Lifecycle Management
for 2 uger siden
Aeven A/S Søborg, Danmark FuldtidStudent Assistants for Application Lifecycle Management (ALM) Project Migration · The Task · As part of migration/separation project, all customers' ALM Quality Center Projects will be migrated from the current installation of ALM Quality Center to a new installation dedicated to ...
-
ASCENDIS PHARMA A/S Hellerup, Danmark FuldtidAre you passionate about quality and GDP and would you like to be a part of our high performing QA Commercial Distribution team in a fast growing and innovative international company? Are you motivated to play an important role in ensuring the quality and compliance of our produc ...
-
IT Specialist Product Lifecycle Management
for 7 timer siden
Arla foods Viby, DanmarkHow you will make an impact · You will be part of the implementation of new tool at Arla and will be trained to manage the solution after implementation. As the primary contact for any improvements, issues, or errors, you will be responsible for resolving problems within the syst ...
-
M365 arkitekt og Tech-Lead
for 5 dage siden
Avenida Consult ApS Hellerup, Danmark FreelanceEr du passioneret omkring Modern Work, M365 og sikkerhed? Har du dybdegående erfaring med Microsoft Modern Work samt stærke færdigheder inden for M365 og sikkerhed, og kunne du tænke dig at dele din viden med kolleger og potentielle kunder? Så kunne du være den rette til stilling ...
-
Cloud Adoption Manager
for 1 uge siden
Oracle Danmark ApS Hellerup, Danmark FuldtidRole and Responsibilities · The Cloud Adoption Manager will collaborate closely, as needed, with the relevant TCE teams to agree on specific activities and/or deliverables required in each of the accounts they are managing. The ultimate goal is to improve usage and usage growth ...
-
Cloud Adoption Manager
for 1 uge siden
Oracle Hellerup, Danmark Regular EmployeeRole and Responsibilities · The Cloud Adoption Manager will collaborate closely, as needed, with the relevant TCE teams to agree on specific activities and/or deliverables required in each of the accounts they are managing. The ultimate goal is to improve usage and usage growth o ...
-
IT Validation Manager for our Dynamics 365 and financial solutions
for 2 dage siden
Ascendis Pharma Hellerup, Danmark FuldtidDo you have a Quality mindset? Are you passionate about GxP validation? · Do you want to make a difference in the way we work with compliance documentation, data integrity and test automation in the pharmaceutical industry? · Now is your chance to join the growth journey in Asce ...
-
IT Validation Manager for our Dynamics 365 and financial solutions
for 2 dage siden
ASCENDIS PHARMA A/S Hellerup, Danmark FuldtidDo you have a Quality mindset? Are you passionate about GxP validation? · Do you want to make a difference in the way we work with compliance documentation, data integrity and test automation in the pharmaceutical industry? · Now is your chance to join the growth journey in Asce ...
-
Document Control Manager
for 1 uge siden
Novo Nordisk A/S - NYx Gentofte, Danmark FuldtidAre you an experienced Document Control Manger? Are you ready to lead a team and make a difference in the world of pharmaceuticals? We are looking for a talented manager to lead a Document Controls team at Novo Nordisk. If you have a strong background in document management and a ...
-
Job - Link ApS Charlottenlund, Danmark TEMPORARYJob-Link is looking for a Projekt Manager with Marine Engineering experience for one of our very successfull International customers in the maritime sector. Our customer is an established and very well known company, that are focusing on designs and development of the future zero ...
-
Staff Data Scientist
for 2 dage siden
Monta ApS København Ø, Danmark FuldtidStaff Data Scientist · Description · Monta's powerful EV platform connects the dots in the entire EV charging industry. · We are looking for a talented Staff Data Scientist to join our team in Copenhagen. As a Staff Data Scientist at Monta, you will spearhead our modeling and alg ...
-
Senior MuleSoft Developer/Specialist
for 3 dage siden
emagine Consulting Søborg, Danmarkemagine is currently seeking a highly skilled Senior MuleSoft Developer/Specialist to manage ongoing integrations development and lifecycle management of APIs and integrations in support of the Submissions and Labelling project for a client in the pharmaceutical industry. · Descr ...
-
Advanced Quality Specialist
for 2 uger siden
Aeven A/S Søborg, Danmark FuldtidAdvanced Quality Specialist (GxP) for our Application Lifecycle Management (ALM) Team · Profile Summary · The Advanced Quality Specialist is responsible for ensuring the quality and compliance of the ALM Quality Center software, The Advanced Quality Specialist will perform variou ...
-
Regulatory Affairs Associate
for 4 dage siden
Reckitt Søborg, DanmarkRegulatory Affairs Associate (all genders), Hygiene · City: Soborg We are Reckitt · Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier ...
-
Regulatory Affairs Associate
for 1 uge siden
Reckitt Søborg, DanmarkRegulatory Affairs Associate (all genders), Hygiene · City: Soborg We are Reckitt · Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier ...
-
Project Manager for Labelling
for 1 uge siden
Novo Nordisk A/S - VTx Søborg, Danmark FuldtidAre you ready to take on impactful projects and drive the implementation of complex regulatory requirements? Do you have a passion for improving processes and setting the direction for labelling coordination? If so, we have an exciting opportunity for you to join our Labelling Co ...
-
Value Strategy and Payer Engagement
for 2 dage siden
Novo Nordisk Søborg, DanmarkThe position · As the Associate VSPE Director you will be in charge for the development of the value strategy and market access planning for key pipeline products in Obesity. You will be informal lead of a matrix access team and you will collaborate with other Global functions a ...
-
Novo Nordisk Søborg, DanmarkThe position · includes some traveling activities. The workplace is our office buildings in Søborg but we can also offer flexible working. We do as well support you with a mobility package when moving from your home country. Qualifications To be successful in this role you will ...
-
Senior International Medical Manager
for 1 uge siden
Novo Nordisk Søborg, DanmarkThe position · includes some traveling activity. Qualifications We're looking for candidates who have a university degree as a Medical Doctor and scientific training at PhD level or similar. Experience with clinical development of pharmaceutical drugs, medical devices, or Softwa ...
-
Senior International Medical Manager
for 1 uge siden
Novo Nordisk A/S Søborg, DanmarkAre you a Medical Doctor with an interest in clinical development of pharmaceutical drugs, medical devices and digital health? Would you like to be part of our medical and scientific team supporting our portfolio of medical device projects across diverse therapeutic areas? Is con ...
QA manager/Sr. Specialist, GDP and commercial lifecycle management - Hellerup, Danmark - Ascendis Pharma
Beskrivelse
Are you passionate about quality and GDP and would you like to be a part of our high performing QA Commercial Distribution team in a fast growing and innovative international company? Are you motivated to play an important role in ensuring the quality and compliance of our products and processes?
The role
As our new QA manager/Sr. Specialist, you will play a pivotal role in supporting the distribution of our products globally and contributing to ensuring supply of Ascendis Pharma's products to patients worldwide. As Ascendis Pharma rapidly expands the global footprint by launching commercial products the need increases to maintain a robust distribution setup and build and develop a supportive organization and processes. Our new QA manager/Sr. Specialist will therefore be involved in these activities as well as assuring seamless and effective communication with our stakeholders, including internal SMEs and international partners.
You will join a group of competent and very dedicated colleagues in our newly established QA Commercial Distribution team, working directly with our rapidly expanding global commercial organization.
Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
You will be responsible for:
Your professional qualifications
We are seeking a skilled and motivated person to join our team, that can support our exiting and dynamic everyday business.
More specifically we are looking for:
As a person you are:
Travel: estimated around 10-15 days per year.
Office location: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.
For more details about the company please visit our website or reach out to Freja Aksel Jacobsen, Associate Director, QA Commercial Distribution on or All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received, so please apply as soon as possible.
Benefits: