QA Manager Finished Products and Packaging
Ascendis Pharma, Denmark

Ascendis Pharma A/S, a visionary and ambitious company, offers you an opportunity to become a major participant in the further establishment of the structure and function of QA Commercial Operations. 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.

As QA Manager for Finished Products and Packaging, you will hold the key competence within quality oversight of Finished Products and Packaging processes. You will be involved in validation of packaging processes, establishment and approval of printed packaging materials and the review and approval of packaging batch records.These activities also include validation of serialization for US and EU and participation in investigations of serialization errors.

You will collaborate closely with the responsible persons for QA for Drug Products and Drug Product Manufacturing areas internally in Ascendis Pharma and externally with contract manufacturing organizations (CMOs) in US and EU.

Your key responsibilities:

• Provide Quality Assurance input to the development, validation and manufacturing of commercial printed packaging materials, and ensure that all activities are conducted in compliance with Ascendis’ QMS and relevant regulatory requirements
• QA review and approval of printed packaging materials from CMOs
• Review and approve validation activities of packaging processes
• QA oversight of manufacturing and packaging activities for commercial use, and approval of batch records
• Follow-up with CMOs on packaging deviations
• Make quality assessments of changes to packaging processes, materials, design and procedures and ensure applicable and appropriate documentation
• QA oversight of Serialization for US and EU, and participate in investigations of serialization errors
• Participate, as Packaging Quality Specialist, in compliance audits of CMOs
• Keep abreast with changes in relevant packaging requirements and ensure cGMP at Ascendis and CMOs

The ideal candidate:

You hold a relevant master’s degree combined with 5-10 years of experience from working with printed packaging materials, commercial packaging processes or quality assurance. You have extensive knowledge of International, US and EU printed materials requirements and pharmaceutical packaging regulations and standards, and experience from working with quality aspects of packaging and GMP in general. As you will have frequent, direct communication with CMOs, you must haveexcellent English communication skills, both spoken and written

As a person, 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.

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 Ascendis’ ambitious corporate goals. You will be part of an expanding QA-organization overseeing development, clinical, and commercial activities.

Travelling: 10 15 days/year

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.

Please submit your application as soon as possible as we will interview on an ongoing basis. This position will be closed once the right candidate has been found. All applications must be in English and are treated confidentially.

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