Senior QA Project Manager for Drug Development Projects
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Are you passionate about quality assurance in the pharmaceutical industry? Do you have a knack for project management and a desire to make a significant impact and ensuring the quality in drug development? If so, you might be the perfect fit for our Senior QA Project Manager position, specifically for CMC development, at . Read more and apply today for a life-changing career. The position
In this role, you will ensure quality oversight for drug development products, serving as the central QA representative in strategic project teams. Your responsibilities include setting clear quality direction across the entire value chain, representing QA and ensuring quality oversight from early to late phase clinical development across diverse therapeutic areas such as Diabetes, Obesity and Rare Diseases. In addition, you will join a team with a positive atmosphere where colleagues actively support and assist each other. As a Senior QA Project Manager, you can look forward to a broad range of exciting challenges that have the attention of senior management while also supporting your personal and professional development. Your responsibilities will include: Ensure quality oversight for development projects approaching first human dose and throughout the development towards launch. Representing CMC Development QA in CMC Core Teams. Planning, coordinating, and following up on QA project activities to ensure timely delivery. Proactively addressing potential quality issues in development projects and include quality aspects in project strategies and development plans. Serving as the one-point-of-entry from Contract Manufacturing Organisations (CMOs) to CMC QA and preparing and negotiating Quality Agreements with CMOs. Contribute to and endorse project strategies. 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 To succeed in this role, you should: Hold a Master's degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar. Have at least 5 years of solid experience preferably within or other pharmaceutical company. Demonstrate experience in QA and Project Management within drug development. Experience from working with CMO’s in GMP regulated environments. Have in-depth or specialist experience with GMP guidelines and regulations. Proficiency in English in both written and spoken. As a person, you possess excellent collaboration and communication skills, along with strong project management abilities, showcasing your capacity to drive successful outcomes. You have a proven ability to set a clear quality direction, contribute to solving complex challenges Furthermore, your high level of independence, personal engagement, and drive reflect your commitment to achieving high-quality outcomes.
About the department Product Development (PD) QA is a new area in PSQIT established to gather all QA responsibilities for the Development Product Portfolio (DPP). The new organization will act as a QA single point of entry into PSQIT providing an end-to-end quality overview, ensuring the quality strategy for commercial scalability and manufacturability from early development to life cycle management. DPP QA consists of approximately 25 highly skilled employees. You will become part of a department with many interfaces across the organization across Denmark and our international production sites. We work towards continuously improving our competences, as well as making work processes more efficient and effective.
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 60,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Susanne Bert Midtgaard, Senior Manager at +. Deadline 13 March 2025. 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.
In this role, you will ensure quality oversight for drug development products, serving as the central QA representative in strategic project teams. Your responsibilities include setting clear quality direction across the entire value chain, representing QA and ensuring quality oversight from early to late phase clinical development across diverse therapeutic areas such as Diabetes, Obesity and Rare Diseases. In addition, you will join a team with a positive atmosphere where colleagues actively support and assist each other. As a Senior QA Project Manager, you can look forward to a broad range of exciting challenges that have the attention of senior management while also supporting your personal and professional development. Your responsibilities will include:
Qualifications To succeed in this role, you should:
About the department Product Development (PD) QA is a new area in PSQIT established to gather all QA responsibilities for the Development Product Portfolio (DPP). The new organization will act as a QA single point of entry into PSQIT providing an end-to-end quality overview, ensuring the quality strategy for commercial scalability and manufacturability from early development to life cycle management. DPP QA consists of approximately 25 highly skilled employees. You will become part of a department with many interfaces across the organization across Denmark and our international production sites. We work towards continuously improving our competences, as well as making work processes more efficient and effective.
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 60,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Susanne Bert Midtgaard, Senior Manager at +. Deadline 13 March 2025. 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 "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Nordsjælland
Jobbet er oprettet på vores service den 26.2.2025, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Projektleder
- Nordsjælland
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