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Director Local Manufacturing QA

Would you like to take QA responsibility for all Novo Nordisk outsourced drug products at local manufacturing sites and local CMO’s? Would you like your decisions to have major business impact across key markets in our International Operations and work in an area that make a difference to patients’ lives every day? If yes, it’s the most perfect time to join Local Manufacturing QA!

About the department:

Local Manufacturing (LM) QA is responsible for the quality assurance of the local manufacturing projects that establish and operationalise local production abroad. After operationalisation we are overall accountable for quality from all local sites. On an operational level LM QA is part of the release flow from CMO’s in operation (India, Bangladesh, Belarus and Saudi Arabia) and involved in compliance tasks, deviations and change requests and new projects at both CMO’s and local NN sites.

As Director of LM QA you will head a global leadership team consisting of four local quality heads (with dotted reporting lines) and two locally based CMO-quality partners. The quality organisation in Local Manufacturing includes more than 100 global QA and QC employees, of which eight highly qualified employees are located in Denmark. You will be heading up a department where Key Behaviors are driving a strong culture, and where clear quality direction setting is complimented by quality oversight and ability to support and drive improvements. Engagement and communication with all levels of employees across different cultures is a key part of the job.

The position

You will assume a key role in continuing to lead, develop and shape the LM QA department. You will act as a role model for NNWay and Quality Mindset. In close collaboration with our stakeholders you assure that the quality of products and processes are compliant with external and internal GMP requirements.

You will be the QA partner for the CVP of Local Manufacturing which includes being a member of the local management team. You are expected to conduct regular quality review meetings, with internal and external stakeholders, to ensure oversight of quality activities and secure robust agreements are made. Meetings are held both virtually and on- site, so travelling activities of 30 days a year should be expected.

In your role, you will refer directly to the Corporate Vice President of D&S QA and be a member of the management team. You will have an important role in the management and development of the D&S QA organisation as well as driving prioritisation, strategies and setting direction for quality and compliance across sites.

Qualifications:

  • M.Sc. in engineering, chemistry, biotechnology, biochemistry or similar, and you have a broad understanding of the pharmaceutical value chain. You have substantial experience in quality assurance in a pharmaceutical production and a deep insight in the GMP regulation and especially validation requirements.
  • You are an experienced leader and people manager with a solid track record. You have a visible leadership style and are able to listen, coach and motivate your employees to deliver their best.
  • We are looking for a person with a strong business perspective who can understand both the quality requirements and the production business with an ability to balance quality, delivery and cost.
  • You have a minimum of 5 years of experience within the pharmaceutical industry including aseptic production and GMP.
  • You seek influence in quality matters and are comfortable being challenged by senior stakeholders and your high level of personal integrity and robustness enables you to integrate different views in the decision making process. Having said that, we expect you can stay firm when needed to secure the quality and compliance aspects.You are well organised and create strong results by engaging your employees in taking pride in delivering on their objectives. Your ability to communicate clearly and collaborate is highly required and you are fluent in English both in speaking and writing.

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