QA manager/Sr. Specialist, GDP and commercial lifecycle management

Are you passionate about quality and GDP and would you like to be a part of our high performing QA Commercial Distribution team in a fast growing and innovative international company? Are you motivated to play an important role in ensuring the quality and compliance of our products and processes?

The role
As our new QA manager/Sr. Specialist, you will play a pivotal role in supporting the distribution of our products globally and contributing to ensuring supply of Ascendis Pharma’s products to patients worldwide. As Ascendis Pharma rapidly expands the global footprint by launching commercial products the need increases to maintain a robust distribution setup and build and develop a supportive organization and processes. Our new QA manager/Sr. Specialist will therefore be involved in these activities as well as assuring seamless and effective communication with our stakeholders, including internal SMEs and international partners.

You will join a group of competent and very dedicated colleagues in our newly established QA Commercial Distribution team, working directly with our rapidly expanding global commercial organization.

Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.

You will be responsible for:

• 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.

Your professional qualifications
We are seeking a skilled and motivated person to join our team, that can support our exiting and dynamic everyday business.

More specifically we are looking for:

• 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.

As a person you are:

• 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.

Travel: estimated around 10-15 days per year.

Office location: 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 company please visit our website www.ascendispharma.com or reach out to Freja Aksel Jacobsen, Associate Director, QA Commercial Distribution on +45 6161 3409 or [email protected]. All applications must be submitted in English and are treated confidentially.

Applications will be evaluated when received, so please apply as soon as possible.

Benefits:

• 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.

Hellerup