QA Specialist, QA for QC Commercial Department, Ascendis Pharma A/S / 1809
Ascendis Pharma A/S a publicly held, biopharmaceutical company founded in Copenhagen, Denmark in 2007, 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
Ascendis Pharma is a visionary and ambitious company that offers you an opportunity to become a major participant in the further establishment of the structure and function of QA Commercial department. You are offered a position with potential to grow your professional and personal skills and to be part of the introduction of new products to be marketed and support established commercial production.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a nice view of the harbor, the canals, and the sea.
QA Specialist, QA for QC Commercial Department
Join the QA Commercial Department in a leading and fast-growing biotech company
- You join an organization with highly skilled and experienced colleagues
- Great opportunity to develop with the task and the team
- You are positive and see opportunities instead of difficulties
As QA Professional/Specialist, you will be part of a dynamic and competent team contributing to the development of the QA Commercial Operations Department and get the opportunity to contribute with your knowledge and experience. The group is based on a strong team spirit, cooperation, and willingness to help and go the extra mile for each other when needed.
Your role will specifically focus on QA oversight of outsourced analytical testing for starting materials, intermediates, Drug Substance and Drug Product. You will support and conduct review- and approval of i.e., analytical documentation, quality system records such as deviations, change controls and CAPAs and other operational related documentation. Moreover, you contribute actively to the department relevant projects such as continuous upgrades of quality systems SOPs, support launch activities, execution of regular quality management reviews, IT projects etc. Finally, you work to ensure continuous good relations and alignment with CMOs worldwide and stay updated with insights into their methods and processes.
You will report to the Sr. Director of QA Commercial Operations and be a key part of the Commercial QA Management Team. Travelling: Approx. 15-20 days per year.
Main areas of responsibility:
- Review and approval of analytical documentation from CMOs and/or testing laboratories, including but not limited to laboratory records, deviations, laboratory investigations, OOS, change controls, CAPA´s, and stability protocols, reports etc
- Follow-up on trends with Ascendis Subject Matter Experts and CMOs to ensure methods and processes are improved
- Support commercial Ascendis Pharma Quality Management Review process, the annual product quality reviews, and other projects
- Review and give input to Quality Agreements
- Participate as needed in inspections and internal and external auditing
- Communication with CMO´s including face-to-face meetings and teleconferences
- Develop and implement GxP improvement projects for systems and procedures including SOP´s, policies, forms, and tools
- Keep up to date with changes in relevant guidelines and regulatory requirements and ensure cGMP at Ascendis Pharma and CMO´s
You bring 5-10 years of relevant experience from Quality Assurance and/or Quality Control from the life science industry combined with relevant Master of science in Pharmacy, Chemistry, Biotechnology, Engineering or similar.
It is a great advantage if you have experience from commercial operations, including participation in various projects as a QA representative. You are used to work with Quality Systems including deviations, change controls and CAPA´s. Proficient in English at a professional level, both written and spoken. At Ascendis Commercial QA we work primarily with electronic records and documentation in electronic systems so an intuitive understanding of electronic systems is also a great advantage as well as solid experience of standard Microsoft tools like MS office, MS Teams, SharePoint etc.
You have experience within the regulatory field and regulations as well as experience with guidelines for analytical methods. Furthermore, you are competent within stakeholder management and possess a good business understanding.
You are meticulous with a high level of attention to details. You are clear and persistent in your expectations and requirements to quality, while at the same time being pragmatic and flexible in your approach. You are self-motivated and able to work independently and finally you can communicate clearly, both internally and externally towards CMOs and other stakeholders.
As a person you bring energy and a positive mindset, and you enjoy being part of a team with many and varied tasks and functions. You will join a skilled and helpful team in an exiting environment with great flexibility.
Best Talent is responsible for the recruitment process and will be handling your application on a confidential basis. Forward your application in English marked ”1809/QA for QC” to email@example.com. Read more about Ascendis Pharma on www.ascendispharma.com. We will interview candidates for this position ongoing, but please apply as soon as possible. You can read more about Best Talent at www.besttalent.dk.