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QA Manager for Fill and Finish Expansions

2 weeks ago


Kongens Lyngby, Denmark Novo Nordisk AS Full time

Select how often (in days) to receive an alert: Create Alert

QA Manager for Fill and Finish Expansions

Category: Quality

Location:
Lyngby, Capital Region of Denmark, DK

Do you have leadership experience and a passion for shaping the future of production in Novo Nordisk? If so, we invite you to apply for the Manager position at Fill & Finish Expansions QA (FFEx QA). This is an exciting opportunity to lead a dedicated team and drive our quality assurance initiatives forward.

The position
As Manager, you will lead a team of 11 skilled employees, including QA professionals and Project Managers. Your team will play a crucial role in ensuring the quality and compliance of our pharmaceutical production processes.
Key Responsibilities

  1. Team Leadership: Guide, coach, and mentor your team, setting direction and fostering individual growth.
  2. Quality Compliance: Ensure adherence to internal and external quality standards and regulatory requirements (cGMP).
  3. Operational Readiness: Develop and challenge program direction to ensure efficient and transparent systems, structures, and processes.
  4. Stakeholder Alignment: Collaborate with other areas within FFEx to establish clear roles and interfaces.
  5. Strategic Partner: Provide strategic and tactical direction to the head of the department.

The Team's Function

  1. QA Support: Provide operational readiness QA support for the entire pharmaceutical value stream including sterilization, formulation, filling, inspection, assembly, packaging, intralogistics, and warehousing.
  2. Project Management: Oversee quality-related processes to ensure our systems are future-ready, including (but not limited to) instant release portfolio and batch release processes.

Global Collaboration
In this role, you will collaborate with global sites in the USA, China, Brazil, and Europe, requiring some international travel. Your ability to build relationships with stakeholders across these locations will be key to your success.

Qualifications
As a Manager, you will need excellent communication skills and the ability to build relationships with cross-functional and global stakeholders. You must excel in a dynamic environment where change is a constant.
To thrive in this role, you should possess the following:

  1. An academic degree in Engineering, Chemistry, Pharmacy, or a related field.
  2. 2-3 years of leadership experience, demonstrating your ability to lead and inspire teams.
  3. A strong quality mindset with proven experience in quality systems within pharmaceutical manufacturing.
  4. Comprehensive understanding of cGMP, validation requirements, and aseptic production.
  5. Fluency in written and spoken English is essential; knowledge of Danish is advantageous but not required.

On a personal level, you should enjoy working closely with your team, coaching, and motivating colleagues to achieve timely results. You are a driven, problem-solving individual who is always keen to explore new opportunities and possibilities.

About the Department
FFEx QA Operational Readiness and QC is part of Investment Portfolio QA (IP QA) and supports the expansion program (FFEx). This program aims to increase the aseptic and finished production capacity across the Novo Nordisk network, ensuring we continue to deliver high-quality products for our patients in the future.

Our department holds global responsibility for quality assurance and compliance for operational readiness and quality control of new facilities. We also ensure that our quality processes fit our new facilities and align with our ambitions. We maintain a high level of quality and GMP compliance in close cooperation with our stakeholders, collaborating internationally with QA for the new facilities.

You will be part of a team that works in a vibrant and positive environment, valuing the exchange of knowledge and experience. Networking and cooperation are key to our success.

Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.

Contact
For further information, please contact QA Director, Klaus Castagni Parasole Volhøj at +45 30756137 or email

Deadline
2nd Feb 2025
Please note that interviews may start before the deadline, so feel free to submit your application as soon as possible.
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.

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