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Senior Vice President, Global Chief Medical Office

We are seeking a highly experienced and dynamic medical executive to join our Global Research & Development organisation in a newly established senior leadership role as SVP, Global Chief Medical Office (GCMO).

In this role, you will act as scientific advisor to the EVP of R&D and the Global R&D leadership team, and your primary objective will be to ensure “one global medical voice” for ALK internally and represent the medical voice of ALK externally.

Senior Specialist til QC hos Xellia Pharmaceuticals

Drømmer du om mere ansvar, med forskelligartede opgaver, og har du en passion for mikrobiologi? Vil du spille en central rolle i Xellias produktionen af livsvigtig antibiotika?

Som senior specialist vil du blive faglig ansvarlig for vores count release-laboratorie, som bl.a. udfører TVC- og LAL-analyser. Derudover vil du indgå i tæt samarbejde med vores sterile produktioner angående EM, hvor de nye Annex 1-krav stiller øgede krav til vores compliance, som du vil spille en vigtig rolle i.

Biocompatibility Specialist

We are looking for a Biocompatibility Specialist to join the Reprocessing and Biocompatibility team for a 12-month project position.

This is a great opportunity if you would like to gain experience with biocompatibility for advanced reusable medical devices, as you will be part of a cross-functional effort on documenting the safety and performance through the lifetime of our ultrasound scanners, transducers, and accessories.

QA Specialist

We are seeking a competent new colleague to join our QA team in a dynamic and growing company.

You will be part of our highly dedicated team consisting of 5 colleagues working with a broad range of QA tasks such as batch review, processing of complaints, deviations and change requests as well as validation and ad hoc projects.

Training Partner

Are you passionate about designing high impact training to improve ways of working?

The role will focus on re-designing the training related to onboarding our professionals working directly with our operation, our Operators, and our Laboratory Technicians.

You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words.

Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Senior Regulatory Specialist

The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.

If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

Fleksibel og nysgerrig QA-koordinator med lederpotentiale

Kan du se dig selv stå i spidsen for at sikre høj kvalitet for mere end 1500 forskellige produkter årligt?

For Persano Group søger vi en QA-medarbejder, som kan se sig selv vokse ind i en ledende funktion, og som har den rette mængde af drive, nysgerrighed og ejerskab til at bidrage i en familiedrevet virksomhed, hvor stor passion er den kultur, der gennemsyrer virksomheden.

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders

Senior Engineer Device Manufacturing

Are you passionate about cutting-edge medical technology? Do you thrive in a collaborative environment where innovation drives patient care?

Amgen, a global biotechnology leader, is expanding its device development capabilities in Denmark and is seeking a talented Senior Engineer to join our Device Engineering group.

QA Specialist og Senior QA Specialist

For dig, der trives med at arbejde med kvalitet og lovgivning fra et operationelt perspektiv, både selvstændigt og i dialog med vores leverandører og interne afdelinger.

Som QA Specialist vil du være det koordinerende bindeled mellem de forskellige teams i QA, regulatorisk og Pharmacovigilance i relation til udfærdigelse eller opdatering af eksisterende TA.

Senior Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

You will become a process owner of one or more of our production processes in SFI. This means that you will be responsible for, among other things, validation documentation, revalidations, and risk assessments for the specific process.

Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

Together with the rest of the team, you will be responsible for the daily support of our production lines. You will learn our processes in detail and gain a good overview of the documentation used in production.

Technical Writer to GE HealthCare Denmark

Join GE HealthCare to help develop high quality instructions for use for our ultrasound scanners, transducers, and reprocessing methods in compliance with rules and legislation in various countries. This is your opportunity to become part of an innovative team where your work has a real impact on people’s lives around the world.

Our Technical Documentation team consists of six dedicated and passionate specialists with a mix of seniority, educational backgrounds, and nationalities. Our Technical Writers develop and maintain the user documentation for our high-performance equipment.

QA Specialist

You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.

You will have the opportunity to:

• Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.

Continuous Improvement Partner

As a Continuous Improvement Partner in Drug Substance Manufacturing, you will be part of a team of Improvement Partners who develops and sustains systems and tools that enables the organization to consistently increase the level of operational excellence in manufacturing.

Your primary tasks will include but not be limited to:

• Develop and sustain CI systems and tools.
• Coach on ideal behaviour that drives a proactive improvement culture.

Senior Technical Writer - Regulatory (CMC)

You will join the Technical Writing team within Global Regulatory Affairs. We are responsible for global regulatory CMC writing of regulatory documents in applications for new approvals, worldwide market expansions, and product lifecycle activities. We work with a variety of pharmaceutical products, including small molecules, peptides, biologicals, recombinant products, and gene therapy.

Stepping into an informal and collaborative environment, you will have close interfaces with many different disciplines, including Global Pharmaceutical R&D, manufacturing sites, Product Supply, Quality Assurance, Ferring affiliates, and development sites around the world.

MS&T Program Manager

We are looking for an experienced professional from the pharmaceutical industry, who can effectively manage project plans across multiple entities and lead cross-functional processes within our own sites and supply chain.

As a MS&T Program Manager, you will be responsible for managing the projects, maintaining project databases, as well as ensuring effective communication and timely achievement of milestones.

Manufacturing Science & Technology (MS&T) Technical Transfer Project Manager (Sr Specialist)

Join Orifarm and take charge of building strong business relationships with a key portfolio of our suppliers!

As a MS&T Technical Transfer Project Manager, you will be responsible for securing technical support to Supplier Relationship Management functions, and manufacturing sites comprising support, technological transfers between CMOs and own manufacturing sites, analytical method development and validation, external product development at CDMOs and driving continuous technological improvement and innovation.

QA Team Manager

Er du passioneret omkring ledelse og udvikling, og kan du overføre glæden til et team af dedikerede specialister? Har du derudover erfaring indenfor QA og GMP, så har vi en interessant mulighed i vores Life cycle management og release afdeling.

I rollen som Team Manager bliver det din opgave at supportere et inkluderende miljø og fordre effektivt samarbejde i teamet af dygtige QA-medarbejdere. Derfor er det vigtigt, at du evner at specificere opgaver klart og tydeligt, definere mål og prioriteter, samt at du kan kommunikere og uddelegere ansvar i dit team.