Senior QA Professional

19 hours ago

HøjeTaastrup Kommune, Denmark Novo Nordisk AS Full time

Do you want to be part of expanding our CMO business, to have international business impact and are you ready to make a difference for millions of patients? Are you passionate about Quality Assurance and Quality Management Systems (QMS)? Do you want to work in one of the most interesting and challenging areas in Novo Nordisk and eager to take your professional career to the next step?

If your answer is yes and you have the ability to engage, set quality and compliance direction and mobilize people with different cultural backgrounds in an ever-changing international setting, you could be our new colleague in our QA AP or FP Project teams in Global Contract Manufacturing Drug Product QA (GCM DP QA).

The Position
In this role, you will collaborate with a team of highly experienced Quality Assurance (QA) colleagues to ensure quality and drive progress across our global project portfolio. As we onboard new Contract Manufacturing Organizations (CMOs) to manufacture products for millions of patients worldwide, you’ll join us at an exciting time of expansion into new business areas.

You will play a leading role in all project phases, including building strong partnerships with CMOs, overseeing technology transfers, qualifying equipment and facilities, and validating processes. With CMOs located outside Denmark, you can expect approximately 25 travel days annually to support onsite activities.

As part of our skilled QA team, you will deliver best-in-class QA, working closely with Line-of-Business (LoB) colleagues to uphold the highest production standards at our CMOs.

Your main responsibilities will be to:

  • Lead Quality Assurance (QA) in market and capacity expansion projects, setting quality and compliance direction.
  • Ensure QA oversight, Good Manufacturing Practice (GMP) compliance, and project progress across all phases.
  • Oversee qualification of equipment, facilities, and validation of production lines, including aseptic processes, Quality Control (QC), and packaging.
  • Build strong collaboration with Contract Manufacturing Organizations (CMOs), fostering a quality mindset and compliance culture through training, coaching, and mentoring.
  • Manage high-level tasks in an international setting, leveraging cross-functional skills to engage and energize local teams.

We expect you to work independently, apply your expertise, identify best practices, drive process improvements, share knowledge, and empower your colleagues to learn and excel.

Qualifications

To be considered for this role, you should have:

  • M.Sc. within Pharmacy, Chemistry, Biotechnology Engineering, Science or similar.
  • Proven experience working with either aseptic, assembly or packaging production in QA organizations within pharmaceutical manufacturing.
  • Experience with EU and/or US GMP requirements, business understanding within pharmaceutical products, qualification and validation, collaboration in an international environment, relation building and stakeholder management.
  • Fluency in English, both written and spoken. Knowledge of other languages is an advantage.

As a person you are energetic, driven, and eager to learn, with a positive and open-minded approach that inspires those around you. Your strong quality mindset, diplomacy, and cultural awareness enable you to lead with authority, engage teams, and collaborate effectively in international settings.

About the department
The position will be part of GCM DP QA Projects currently consisting of 20 colleagues organized in three teams. GCM DP QA Projects support projects globally, however the focus for these positions are Europe and North America. GCM DP QA is responsible for quality assurance and quality support to outsourced production activities worldwide. It is a dynamic department consisting of 80 competent people divided into 11 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Deadline
January 24th, 2025.
We will review applications received on an ongoing basis, so do not hesitate to apply today. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

#J-18808-Ljbffr

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