Senior QA Professional for Quality Oversight of Contract Manufacturing Organisations
Søborg
Are you looking for a place to feed your enthusiasm for quality? Are you excited about playing a crucial role in ensuring quality processes in ’s global network of Contract Manufacturing Organisations (CMOs)? Most importantly, are you eager to contribute your energy to a diverse team that works hard to bring benefits to our patients and stakeholders? Working in our team you will have both great professional and personal development opportunities in a well-functioning department.
We can offer you a great working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. We would enjoy welcoming a straightforward person with a good sense of humor to our department. The position
As a QA Professional you will be responsible for quality assurance of contract manufacturing and will be responsible for one or more CMO`s. You will have to offer QA support and GMP guidance to our partners and do the final release of the API and intermediates from CMO`s to the further process in Novo Nordisk.
Also, you will be responsible for: Ensuring that our outsourced products are manufactured according to cGMP and our marketing authorisations. Daily interactions with internal and external business partners, involving complex tasks. Handling a wide variety of tasks and facing daily challenges. Oversight of QA activities typically conducted by contract manufacturers. Managing documentation from contract manufacturers as part of the role.
Since the manufacturers are located outside Denmark, you are expected to travel 15-20 days a year. Qualifications
To succeed in this role, you should: Hold an academic degree as a Pharmacist, Engineer, or similar. Possess at least four years of experience in a pharmaceutical organization and demonstrate solid and up-to-date knowledge of quality and GMP requirements. Have Experience in handling Non-Conformity (NC), Corrective Actions and Preventive Actions (CAPA), change control, complaints, Annual Product Review (APR), and validations. Ideal candidate is a Qualified Person (QP) delegate and/or has thorough knowledge of quality assurance of pharmaceutical manufactured products. Proficiency in both Danish and English. With your strong cooperation and communication skills you are able to organise and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mind set and are a team player but are also able to work independently. You thrive on working across departments in an international organisation.
About the department
Global Contract Manufacturing Drug Substance QA (GCM DS QA) is a dynamic department consisting of 40 competent colleagues and is characterised by a high level of professionalism, flexibility and cooperation. The primary role of our department is to deliver QA support and oversight and set direction for our CMO´s worldwide.
We focus on good social relations and well-being in the team and prioritise to make room for fun at work. Our department is currently located in Søborg, Denmark, with plans of moving to the new site in Taastrup, Denmark, in December 2024. Working at 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. 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 Manager Birgitte Madsen Find on +or Manager Lena Ellen Larsen on +. Deadline
11 June 2024. 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 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 can offer you a great working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. We would enjoy welcoming a straightforward person with a good sense of humor to our department. The position
As a QA Professional you will be responsible for quality assurance of contract manufacturing and will be responsible for one or more CMO`s. You will have to offer QA support and GMP guidance to our partners and do the final release of the API and intermediates from CMO`s to the further process in Novo Nordisk.
Also, you will be responsible for:
Since the manufacturers are located outside Denmark, you are expected to travel 15-20 days a year. Qualifications
To succeed in this role, you should:
About the department
Global Contract Manufacturing Drug Substance QA (GCM DS QA) is a dynamic department consisting of 40 competent colleagues and is characterised by a high level of professionalism, flexibility and cooperation. The primary role of our department is to deliver QA support and oversight and set direction for our CMO´s worldwide.
We focus on good social relations and well-being in the team and prioritise to make room for fun at work. Our department is currently located in Søborg, Denmark, with plans of moving to the new site in Taastrup, Denmark, in December 2024. Working at 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. 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 Manager Birgitte Madsen Find on +or Manager Lena Ellen Larsen on +. Deadline
11 June 2024. 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 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg