Job Description

Are you looking for an opportunity to use your quality management and compliance background and work for a world leader in diabetes care, growth hormone therapy, and obesity? If so, then you might be our new Senior Manager, Quality Affairs (QA) for Business Area South-East Asia (BASEA). Join us and be part of a global pharmaceutical company that aims to change patients\xe2\x80\x99 lives. Apply now!

About the department
Business Area South-East Asia (BASEA) is the business area within Region Asia Pacific (APAC) which focuses on the vast opportunities and challenges presented by the 11 countries including Bangladesh, Sri Lanka and Maldives covering around 700 employees over 7 affiliate offices and business entities. With its business area office located in Singapore, we are looking for passionate people within the quality function to join the team.

You will be part of the BASEA Legal, Compliance & Quality (LCQ) team, partnering with affiliates within our business area and representing BASEA quality on the region\xe2\x80\x99s quality management team. You will report to the BASEA LCQ Senior Director.

The position
In this role, you will be responsible for quality management and compliance of the Business Area office, affiliates, and distributors in the BASEA region. This is an individual contributor role with dotted line reports.

• Supports the implementation of Novo Nordisk Quality Management System (QMS) in the BASEA region, ensuring product quality and focus on business-critical issues that may have an impact on the license to operate and inspection readiness. Ensure that the QMS in BASEA region is maintained and in compliance with Novo Nordisk requirements and external requirements.
• Collaborate with BASEA affiliates, distributors, APAC, International Operations and Global teams in achieving quality operations and quality goals in the BASEA region, including allocation of resources and the means as necessary for QA employees to fulfil quality obligations.
• In charge of the overall Quality Assurance and Quality Audits including Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP) audits in the BASEA region. Manage diverted and counterfeit products, additionally, ensure all KPIs and reports adherence.
• Responsible as Quality Point of Contact for distributor implementation of quality standards and protocols in accordance with Novo Nordisk quality system and local quality requirements.
• Facilitate QA training and competency development across the region. Participate and contribute to the training of local affiliates and general procedure training.

Qualifications

• A minimum of bachelor\xe2\x80\x99s degree in Pharmacy/Pharmaceutical Sciences or any Science related discipline is required.
• A minimum of 7+ years of experience in pharmaceutical quality assurance. You should demonstrate a broad knowledge and understanding of the pharmaceutical industry, preferably in a multi-national context.
• Experience with regulatory requirements and health authorities in ASEAN countries would be an advantage but not mandatory.
• You should be familiar interacting with all levels of the organisation, be willing to adopt a hands-on approach to resolve problems and have demonstrated business partnering experience including strong stakeholder management and effective communication skills.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We\xe2\x80\x99re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things \xe2\x80\x93 from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we\xe2\x80\x99re all here - to ensure that people can lead a life independent of chronic disease.

Contact
Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline
3 Oct 2023

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\xe2\x80\x99re life changing.

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