QA Analytical Specialist
Ascendis Pharma, Denmark

Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become a participant in the further establishment and expansion of the QA Development - Biologics Team. You are offered a position with potential to grow your professional and personal skills and to be part of the developing of new biological products for clinical trials.

As QA Specialist, you will be a part of the Biologics Team in the QA Development department, with responsibility to support the development activities of the TransCon programs. This include QA oversight of outsourced activities within analytical development, final method validation and stability testing activities for Starting Materials, Intermediates, Drug Substance and Drug Product.

You are responsible for review and approval of analytical and stability documentation from CMOs to support establishing reliable and robust analytical methods. Moreover, you contribute actively to the project teams regarding QA support, within analytical method development and validation and product stability.

Oversight of GLP laboratories and facilities is within your responsibilities. Additionally, you work to ensure continuous good relations and alignment with CMOs/CROs worldwide and stay updated with insights into their methods and processes. In the area of GLP, oversight coordination and performing audits of CRO facilities and ongoing studies fall under your responsibilities.

Your key responsibilities:

• Review and approval of analytical documentation from CMOs, including but not limited to analytical batch records, deviations, laboratory investigations, OOS, changes, CAPAs, stability studies, etc.
• Review and approval of validation protocols/reports
• Review and approval of analytical methods and specifications
• Review and approval of stability protocols/report
• Represent QA in the project teams, supporting CMC colleagues within Ascendis Pharma regarding analytical subjects
• Communication with key personnel at CMOs, including face-to-face meetings and teleconferences
• Ensure the internal quality management system within analytical development is developed and maintained.
• Develop and implement GxP improvement projects for systems and procedures including SOPs, policies, forms and tools.
• Identify and communicate quality or compliance risks and participate in establishment of appropriate plans to address the risks.
• Schedule, plan and perform CMO, CRO and/or laboratory audits.
• Audit internal processes, submission documents etc. in accordance with the audit plan or as requested.
• Establish quality agreements with CMOs
• Responsible for GLP oversight for our CROs including audits and qualification of new CROs.
• Keep up to date with changes in relevant guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs

The preferred candidate:

If you have some of the following experiences, knowledge, and personal qualities, you might be our ideal and preferred candidate:

• Minimum 10 years of relevant experience and a master's degree
• Experience with development QA
• Experience with analytical development and analytical method validation for biologics
• Knowledge about Analytical Method Validation Guidelines and Regulations
• Experience with CMO collaboration
• Pragmatic and yet with attention to the necessary details
• Clear and persistent in your communication, expectations, and requirements to quality
• Cooperative and Capable of ensuring cooperation with many stakeholders
• Proactive, ensuring that projects receive QA-support on a running basis, and reactive when required.

The position as Senior QA Specialist requires experience with and knowledge of US and EU GMP regulations and requirements. Furthermore, you should be proficient in English and Danish at a professional level, both written and spoken, and you master MS Office.

At Ascendis Pharma, you will be part of a stimulating, informal, and innovative working environment, where you will interact with very skilled colleagues and partners to deliver on Ascendis' ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical, and commercial activities.

Travelling: 10-20 days/year.

Place of work: 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 job or the company, please contact QA Ass. Director, Steinar Severin Solli, M +45 30 24 05 00. All applications must be submitted in English and are treated confidentially.

Job Rewards and Benefits