Director, QA Commercial Drug Substance, Ascendis Pharma A/S / 1807
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.
Director, QA Commercial Drug Substance
Join the QA Commercial Department in a leading and fast-growing biotech company
- You join an organization with highly skilled and experienced colleagues
- You will be involved in activities that are central to the strategy
- You are positive and see opportunities instead of difficulties
QA Drug Substance team, a part of the QA Commercial Operations department, is responsible for oversight of starting materials, intermediates, and Drug Substance for commercial products. You will lead a dynamic team in a stimulating international environment. The group is based on a strong team spirit, cooperation, and willingness to help and go the extra mile for each other when needed. You are a delegating, open minded and a modern leader, who in a natural way always strive for smooth collaboration with your colleagues and external stakeholders.
As Director, QA Commercial Drug Substance, you will lead a team responsible for the oversight of drug substance manufacturing at our CMOs (Contract Manufacturing Organizations). You will become a part of a dynamic and competent department, contributing to the development of the QA Commercial organization and get the opportunity to contribute with your knowledge and experience.
Your responsibility will specifically focus on QA oversight of our outsourced manufacturing for starting materials, intermediates, and Drug Substance. You will be responsible for your teams support and conducting review- and approval of i.e., batch record review and associated manufacturing documentation, quality system records such as deviations, change controls and CAPAs and other operationally related documentation. Moreover, you will assure the team contributes 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 will assure the team works 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.
Ascendis Pharma is a virtual biotech company that works with CROs and CMOs worldwide. Therefore, it is crucial you understand the elements necessary to provide excellent external supplier management and oversight, as well as support the organization in establishing/maintaining relevant quality processes.
Main areas of responsibility:
- Establish and lead a high performing QA team including managerial responsibility for the department with regards to budget, headcount, people, and organizational development.
- Collaborating with internal and external stakeholders to ensure appropriate quality level and cGMP within systems and processes, and at the CMO manufacturing of starting materials, API, and Drug Substance.
- Leading and supporting inspection readiness activities and participating at audits and inspections as needed.
- Support and maintain quality goals and KPIs associated with the commercial manufacturing and the quality system.
- Responsible for QA review and approval of batch records including QP release of commercial batches from CMOs
- Support commercial Ascendis Pharma Quality Management Review process, the annual product quality reviews, and other projects that the department is involved in.
- Communication with key personnel at CMOs, including face-to-face meetings and teleconferences
- Keep up to date with changes in relevant guidelines and regulatory requirements and ensure cGMP at Ascendis and CMOs
You have minimum 10-15 years’ experience, preferably from Quality Assurance, within the life science industry. You have solid experience with commercial operations in an international pharma environment and a proven leadership record. You have solid experience with regulatory expectations and guidelines in relation to the medicinal products industry. Furthermore, you are competent within stakeholder management, and have a good business understanding.
You have a master’s degree preferably in Pharmacy or Natural Science. Strong communication skills are essential in this role, and you are proficient in English at a professional level, both written and spoken, and you master MS Office.
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. You thrive in a high impact position and understand how to apply your skills within leadership to inspire the team. As an open-minded dedicated person, you utilise your high level of energy and can-do attitude to proactively handle the various tasks at hand.
Best Talent is responsible for the recruitment process and will be handling your application on a confidential basis. Forward your application in English marked ”1807/Director, QA Commercial” 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.