QA manager/Sr. Specialist, GDP and commercial lifecycle management
Ascendis Pharma
- Hellerup, Hovedstaden
- Permanent
- Fuldtid
- Ensure quality oversight of stakeholders and support business functions and external service providers in quality matters related to transport and storage of Ascendis Pharma’s drug substances, drug products and finish goods.
- Evaluation and approval of activities related to qualification/validation of transport and storage.
- Evaluation and approval of distribution related deviations, CAPAs and change controls
- Qualification of customers
- Participate and/or perform audits of external suppliers (transport companies and warehouses)
- Provide QA support to global launch activities and lifecycle management
- Initiate and cultivate strong, long-term relationships with key partners based on effective communication and collaboration.
- Provide regular updates to internal stakeholders on the status and success of partnerships.
- Establish processes and/or procedures for the partner collaboration, for i.e., sharing of documents, timely notifications, commitments and for other regulatory obligations, etc.
- Solid experience within QA and GDP regulated areas.
- Strong interpersonal and relationship-building skills.
- Excellent communication and negotiation abilities.
- Analytical mindset with the ability to assess and measure partnership performance.
- Ability to work independently and collaboratively in a fast-paced environment.
- Familiarity with pharmaceutical trends and dynamics.
- You are proficient in English at a professional level, both written and spoken.
- A team player with collaborative mindset building positive relationships and collaborating with others.
- Efficiently organizing and prioritizing tasks to meet deadlines and manage workloads effectively.
- Flexible and agile with the ability to quickly change direction and adapt to new priorities in a highly dynamic work environment.
- Result-oriented while still maintaining open-minded and looking for improved ways of working.
- Keeping the needs and satisfaction of partners and internal stakeholders in mind.
- 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 ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.
- Soft drinks, fresh fruit, and a wide variety of snacks every day, no strings attached.
- 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 will find a way to help you grow.