Associate Director QMS
Join a Fast Growing Biotech Company
Ascendis Pharma A/S, a visionary and ambitious company, offers you an unique opportunity to join the quality leadership team
As Associate Director in QMS, you will be part of the QA department owning the company´s Quality Management System (QMS) and responsible for regulatory compliance programs. You will join QMS department consisting of dedicated specialists and report to Head of the QMS. You will be working cross functionally in Ascendis Pharma with a lot of stakeholders at all levels.
You will have a direct impact in designing a best in class quality management system in an excellent Biotech and Pharma Quality Organization.
You will be an active player in the continuous improvement of the QMS to ensure regulatory compliance to GxP and drive the efficiency of key quality processes as well as ensure readiness for inspections.
Your key responsibilities:
- Maintaining and Improving Ascendis Pharma QMS key quality processes;
- System for supporting life cycle management of suppliers
- Maintaining internal and external audit plan
- Support audits and inspections conducted by regulatory authorities or external partners
- Surveillance of regulatory requirements
- Develop and implement the QMS activities, including the creation and maintenance of relevant policies, procedures, and guidelines
- Drive GxP process improvement initiatives across the organization
The following qualifications are desirable:
- A minimum of 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 global compliance including regulatory GxP inspections
- Extensive experience with supplier lifecycle management
- Extensive experience with internal and external audit management
- Experience with large stakeholder management, metrics reporting to senior management teams
- Experience with Veeva QMS is preferred, if not with experience in similar eQMS
You are an energetic, outreaching and a pragmatic person with an open and communicative approach, and you have the ability to work effectively with employees at all levels and you enjoy being in a position with an international reach. You are flexible, persistent and resourceful.
You are proficient in English at a professional level, both written and spoken. You have excellent presentation skills and are familiar with presenting to authorities and to stakeholders at all levels and functions of the company.
As a person, you are clear and persistent in your expectations and requirements to quality, while at the same time you bring business acumen and are pragmatic and flexible in your approaches. You are meticulous with an appropriate level of attention to details.
You are self-motivated and able to work independently.
You can communicate clearly, both internally and externally towards authorities and other stakeholders.
At Ascendis Pharma, you will be part of a stimulating, informal and innovative working environment where you will interact with both colleagues and partners to deliver on our ambitious corporate goals. You will be part of an expanding QA-organization overseeing R/D, clinical and commercial activities
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues on advancing an exciting product pipeline.
Travelling: Approx. 20 days / year
Office: Denmark, Tuborg Boulevard 12, 2900 Hellerup
Applications will be evaluated when received, so please apply as soon as possible.
All applications must be submitted in English and are treated confidentially.
For more details about the position or the company, please contact Ulrik Tolderlund, Senior Director of QA, Quality Systems & Compliance, +45 5166 6630 or visit our website www.ascendispharma.com
- You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
- Laptop, iPhone, paid internet, and home office equipment
- A thorough and structured onboarding program
- To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we find a way to help you grow.
- Soft drinks, fresh fruit and lunch every day in our canteen.
- Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
- To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.