QA Principal Integration Manager (Denmark, Bagsværd)

Jobbeskrivelse
Placering
Bagsværd, Denmark

Jobkategori
Quality

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Are you looking for an exciting opportunity to lead and set a clear quality direction in the integration of acquired assets into Novo Nordisk? Do you aspire to leverage your strong QA background, your leadership skills and your quality mindset while playing a key role ensuring the quality and safety of new Novo Nordisk products?
If yes, then we have the right position for you as Quality Integration Manager in our newly formed Product Development Quality Integration team (DPQ Integration).
We are expanding and seeking new great colleagues with relevant QA experience and knowledge across different pharmaceutical areas to take the role as Quality Workstream Lead in the Novo Nordisk cross functional Integration projects.

The position
As Quality Workstream Lead, you will play a pivotal role in the leadership of the quality integration team across Novo Nordisk quality functions and ensure a smooth and GxP compliant integration of the acquired molecule, CMC development activities and ongoing clinical studies.
You can look forward to a broad range of exciting challenges and exploring new way of working that have the attention of senior management and support your personal and professional development.
Your responsibilities include project management, setting clear quality direction across the entire value chain, representing QA and ensuring quality oversight from pre-clinical to early- late phase clinical development across diverse therapeutic areas such as Diabetes, Obesity and Rare Diseases.
As our new Principal Integration Manager, you will:

• Lead and manage the quality workstream in a true cross functional environment.
• Establish QA governance structure, project team and define quality workstream objectives and mandate for a new acquisition.
• Be responsible for the Master Quality Integration Plan and associated project planning, meeting activities, alignment with stakeholders and monitor execution of the plan and handover activities.
• Representing quality in the transition and integration of the acquired development project into CMC and ensure to integrate quality aspects into project strategies and development plans. Contribute to and endorse project strategies.
• Ensure quality oversight and control of on-going clinical trials (CT) and all quality integration activities and proactively address GxP and quality issues and potential quality drift in the CT development projects.
• Representing Quality in the Integration Core Team, CMC Core team and other relevant decisions fora.

Qualifications

• A Master's or PhD degree within a relevant field of scientific expertise such as Pharmacy, Chemistry, Chemical Engineering, Biochemistry, Biology or similar.
• In-depth understanding of GxP regulations, requirements, and guidelines for pharmaceutical development, manufacturing and clinical trials.
• At least 5 years “hands on” QA and GxP experience preferably within Novo Nordisk or other pharmaceutical company.
• A proven track record in leading complex projects in an international environment.
• An advantage if you have experience with outsourcing (CDMO/CMO) and/or pharmaceutical partnerships in a GxP regulated environments.
• An advantage if you worked with merge and acquisitions within life science industry.
• Fluency in written and spoken English and preferably work experience from an international environment.

As a person, you have:

• Natural leadership skills with the ability to set direction, seek influence, take leadership and drive results.
• Outgoing and self-driven personality where personal engagement and drive reflect your commitment to achieving high-quality outcomes.
• Have a structured way of working are solution oriented and have a “can-do” attitude.
• Excellent collaboration and communication skills.

About the department
PDQ Integration is a new team in Due Diligence & Integration Quality responsible for the quality integration of acquired corp. assets from due diligence and final deal, driving the transition, initial integration, and handover to the Product Development QA Project organization.
You will become an important player in our new small dynamic team of competent people with long experience within product development and quality assurance of IMP. The department is characterized by a high level of professionalism, flexibility and collaboration.

Working at Novo Nordisk
Novo Nordisk 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. Novo Nordisk 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 Director Jane Lykke Saxbøl at +45 30 75 86 19.

Deadline
5 January 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 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.