Qualification / Validation Specialist within transport

Are you passionate about ensuring safe delivery of products to patients? Do you have experience in transport qualification or validation?

If so, now is your chance to join Ascendis Pharma as our new Qualification / Validation Specialist within transport.

As Transport Qualification / Validation Specialist at Ascendis, you will play a crucial role in the validation of shipping processes for Cold Chain pharmaceutical products, ensuring compliance with regulatory requirements and industry standards. You will utilize your expertise in shipping validation to assess and validate shipping lanes, shipping systems, and procedures to safeguard product quality and patient safety.

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:

• Drive shipping validation activities and projects.
• Generate shipping validation relevant documentation (URS, Protocols, Reports etc.)
• Collaborate with cross-functional teams to develop and implement validation plans.
• Lead transportation studies.
• Support selection and assessment of transport solutions and vendors.
• Support lane risk assessments
• Generate regulatory documentation regarding shipping validation.
• Participate in regulatory inspections, audits, and customer inquiries related to shipping.

As or new Transport Qualification / Validation Specialist you will become part of the Global Logistics and distribution team and report to the Senior Director of Global Logistics and distribution. You will be the lead in the ever-evolving shipping validation landscape which is rapidly growing. Furthermore, you will work closely and with full support from Logistics and various stakeholders across the organization.

Your professional qualifications:
You hold a relevant academic degree and you are proficient in English at a professional level, both written and spoken.

Furthermore, you have:

• Minimum of 1-2 years of experience in qualification / validation, preferably in the pharmaceutical industry.
• Excellent analytical, problem-solving, and project management skills.

You are a person with a positive attitude, and you possess effective communication and collaboration skills, which enable you to establish warm and respectful professional relations internally and externally. You are a “hands-on” individual who is interested in making a difference in a dynamic and exciting entrepreneurial environment. You are passionate, and able to interact effectively with all levels of the organization. You like working in a highly regulated area. Finally, you have a personal commitment to delivering results and succeeding as a team.

Travel: 5-10 days per year.

Office location: Hellerup, Denmark

For more details about the position or the company, please contact Kim Rosendal, Senior Director on M + 28 83 33 30 or [email protected] or visit out website www.ascendispharma.com . All applications must be submitted in English and are treated confidentially.

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

Hellerup