QA Manager for Project and Validation

Job title:

QA Manager for Project and Validation

Company:

Novo Nordisk

Job description

Are you skilled in navigating complex stakeholder landscapes and do you believe in working together is better than working on your own? Do you value good team spirit where everyone is each other’s sparring partners and respect each other’s opinions and knowledge? Do you also have a strong quality mind-set and great interpersonal skills. Do you want to make a difference within leadership and take on the responsibility of an experienced team of QA employees?If this sounds like you, then this might be the right job for you.The positionYou can look forward to a broad range of exciting challenges that have senior management’s attention feeding into your personal and professional development. Your responsibilities include setting clear quality direction across the entire value chain process at Site Ba, representing QA and ensuring quality oversight. As a leader, you will not only coach and shape your team but also improve ways of working with quality assurance.As our new QA Manager for Project and Validation, your responsibilities will be to:

• Manage and lead a team of 15 competent and experienced QA employees.

• Set direction for quality and compliance based on the demands of the authorities and requirements.

• Ensure that production, facilities as well as products are in compliance with cGMP and are living up to regulations for aseptic production.

• Ensure the optimizations integrate quality and compliance to continuously improve in production and quality.

• Maintain close collaboration with the stakeholders and common alignment.

• Represent QA at project steering group meetings and manage project participation from QA professionals.

The team’s key responsibility is to ensure that the validation of production processes, as well as qualification of facilities, equipment, and automation systems, is documented according to current GMP requirements. This is done by involvement in investment and optimization projects, as well as by daily support to production. This demands good collaboration skills and a solution-oriented approach when collaborating with colleagues in the production.In addition to the validation responsibilities, this team also has professionals who drive process group work across product supply, training partner responsibility to the department, and being the cLEAN partner to the department’s management team.In this role, you will refer to the department Quality VP and you will have an active part in the development of the department. Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration, where your contributions will be valuable and make a difference.Qualifications

• Hold a Master’s in a relevant discipline.

• Have at least 3-5 years of solid experience in Quality Assurance and/or Production preferably within Novo Nordisk or other pharmaceutical company

• Demonstrate knowledge and experience in Project Management and/or Validation.

• Balanced in compliance and product quality when making decisions.

• Proficiency in English in both written and spoken. Danish will be an advantage.

As a person, you possess an in-depth understanding of GMP regulations, requirements, and guidelines for pharmaceutical development and aseptic production. Your excellent collaboration and communication skills, along with strong project management abilities, showcase your capacity to drive successful outcomes and manage complex stakeholder landscape.You have a proven ability to set a clear quality direction, contribute to solving complex challenges, and establish quality oversight about business strategies and project scope.Furthermore, your high level of independence, personal engagement, and drive reflect your commitment to achieving high-quality outcomes. The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level.Soft skills:You have a can-do attitude and proactively strive for higher levels of performance not being afraid of being challenged by peers and employees. You are a self-driven and independent person with a high sense of responsibility and initiative. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. Further, it is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better. Lastly, you are well organized and create strong results by engaging your employees in taking pride in delivering on their objectives.

About the departmentOur Quality Assurance (QA) department for Site Bagsværd and we are part of Novo Nordisk’s Product Supply area. We are responsible for quality assurance of the aseptic production in Bagsværd and documentation meets the regulatory GMP requirements working in close collaboration with our stakeholders. Our department consists of approximately 60 dedicated employees being responsible for assuring the quality and compliance of diabetes finished products produced in Site Bagsvaerd. The department is divided into 4 teams (Operations, AP release, QA release and QA Projects and Qualification team) and the open position is in the QA team responsible for projects & validation.ContactFor further information Glauco Sanches +45 3075 3014.Deadline
29th July 2024You 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.Working at Novo NordiskWe are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – 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’re all here – to ensure that people can
lead a life independent of chronic disease.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.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.

Expected salary

Location

Bagsværd, Hovedstaden

Job date

Tue, 09 Jul 2024 22:21:52 GMT

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