QA Manager, Complaint Management
Join a leading and fast-growing biotech company
This position is a unique chance to join a visionary and ambitious company on an extraordinary journey, where you will become part of the Global QA department. Following the approvals in the US and EU of TransCon hGH for paediatric patients, Ascendis Pharma is expanding their Quality System and Compliance team to support and sustain commercial products on market.
As QA Manager, you will become responsible for 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 organisation and towards CMOs.
Criteria of success in the role will be to process complaints according to internal procedures and in collaboration with SMEs and CMOs. Furthermore, you will provide data trend for the complaint process and oversee follow-up activities such as CAPA’s, deviations and change controls related to the activities.
Further, you will have the opportunity for working on quality system activities and projects within Ascendis Pharma’s project portfolio.
Main areas of responsibility:
- Complaint management, incl. support, coordination and contact to stakeholders
- Drive quality improvement initiatives across the organisation
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.
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Partner, Rasmus Meyhoff or Research Consultant, Signe Bülow Hansen on telephone +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.
About Ascendis Pharma
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 meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon™ technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and established advancing oncology as its second therapeutic area of focus. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany and Palo Alto, California. For further information, please see www.ascendispharma.com
Deadline: As soon as possible
Workplace: Tuborg Havn, Hellerup
Company: Ascendis Pharma