Sr. Specialist, Quality Management Systems
Share
Job Location:
Gentofte Kommune - Denmark
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Are you passionate about Quality Assurance Do you have experience within Audits- and Inspection Management
If so now is your chance to join Ascendis Pharma as our new Senior Specialist.
Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.
At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.
We are seeking a passionate Senior Specialist to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in coordinating Inspections and Internal Audits and a supporting role for other important Quality Systems like CAPAs Change Controls Deviations and Supplier Management. You will join a team consisting of dedicated specialists and report to Head of the QA QMS. 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 QA QMS (Quality Management Systems) team consisting of 9 colleagues and report directly to Senior Director and Head of QMSwho is based in Hellerup.
Your key responsibilities will be:
- Coordinating Inspections and Internal Audits at Ascendis Pharma
- Process owner of Audit System in Ascendis QMS
- Supporting the maintenance and improvement of Ascendis Pharma QMS key quality processes; such as CAPA management Deviation handling Change Control Supplier Management etc.
- Development- and training of users in the electronic QMS Veeva Quality Vault
- Document Control Management of GxP documents at Ascendis Pharma
- Drive GxP process improvement initiatives across the organisation
Qualifications and Skills:
You hold a relevant academic degree preferably a Master (or similar) degree within Natural- / Life Sciences.
Furthermore you have:
- Preferably at least 10 years experience within Quality and an understanding of the quality processes and excessive knowledge and application of global regulations and guidelines in relation to the medicinal products industry
- Extensive experience with Veeva QMS is preferred if not with experience in similar eQMS
- Extensive experience with global compliance including regulatory GxP inspections
- Experience with large stakeholder management and metrics reporting to senior management teams
Key competencies/skills/traits/personality:
You are an outreaching and pragmatic person with an open and communicative approach who has the ability to work effectively with employees at all levels. Flexibility persistence and resourcefulness are skills that are highly appreciated and sought at Ascendis. Finally the ability to embrace the Ascendis systems while contributing with value-adding experiences from previous positions will ensure a good match for both parties.
Communication is very important in a virtual company such as Ascendis Pharma. You are proficient in English at a professional level both written and spoken. You have excellent presentation skills and are familiar with presenting- and communicating to both authorities and to stakeholders at all levels and functions of the company.
As a person you are meticulous with an appropriate level of attention to details. You are self-motivated and able to work independently. You appreciate the importance of building relations with colleagues throughout the company preferably by face-to-face cooperation and -communication when possible.
Travel: 20days per year.
Office: Denmark Tuborg Boulevard 12 2900 Hellerup
Apply now.
We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.
To ensure your application is reviewed please submit it through the specified platform - applications sent by email or other channels will not be evaluated.
You can learn more about Ascendis by visiting our website
Applications must be submitted in English and will be treated confidentially.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more
