Senior QP delegate in CMC API QA

4 days ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Jobbeskrivelse

Placering
Bagsværd, Denmark

Jobkategori
Quality

Ansøg nu

Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials and thereby secure and support the development pipeline in Novo Nordisk? If so, we have an exciting possibility waiting for you as Senior QP delegate in Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA. Read more and apply now

We offer you a unique position with a lot of impact in a dynamic environment and an opportunity to really develop your skills professionally and personally. For an introduction to the area we support - CMC API Pilots - please visit our career page.

The position
We are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline. You will also be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies in the manufacturing of APIs.

Your key responsibilities will include:

• Ensuring best-in-class quality assurance of our API for clinical trials in phase I, II and III testing.

• Challenge and approve documents related to the development, manufacture, stability, and status assignment of internal and external produced API.

• Ensuring that our products used in clinical trials are following the information provided to Health Authorities worldwide.

• Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.

In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development & Scaling. Join us in making a difference in the lives of people participating in clinical trials, by ensuring safe and high-quality products, manufactured in compliance with legislation.

Qualifications
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, make decisions and follow-up on quality related problems.

To succeed in this role, you should:

• Hold a Master in Pharmacy, Engineering, Biology, Chemistry or similar to fulfil the requirements to become a "Qualified Person" (QP), according to The Danish Medicines Agency certification.

• Have extensive experience in a pharmaceutical company, ideally also in a QA role.

• Possess a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production, and hence can navigate without adding complexity.

• Be proficient in English and Danish.

• Proficiency in SAP and/or PasX along with experience with API and CMOs, will be seen as an advantage.

On a personal level, you are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on top of the agenda, and you like working with many different stakeholders – internally and externally.

About the department
CMC API QA is a department which employ 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for all clinical trials within Novo Nordisk. We also have the responsibility of releasing API from contract manufacturers across the globe. You will be part of the Product & Celle Bank team consisting of both QP delegates, QA professionals and QA assistants.

Our team's culture ensures a healthy and fun working environment where we value strong relationships, people growth and optimisation of our processes. Our main purpose is to safeguard patient safety and ensure product quality and compliance in the CMC area, and ultimately release API for clinical trials. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, to ensure Novo Nordisk's critical delivery of medicine to patients.

Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we're all working to move the needle on patient care.

Contact
For further information, please contact QA Manager Michael Kongsgaard +45 3448 2627.

Deadline
31 July 2024.

Please note that interviews will be scheduled as soon as relevant candidates are identified, so we encourage you to apply sooner rather than later.

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.

#J-18808-Ljbffr

  • Senior QP Delegate in Pharmaceutical Quality Assurance

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job OverviewWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. As a Senior QP delegate, you will play a crucial role in ensuring the quality and safety of products for clinical trials and securing the development pipeline in Novo Nordisk.The successful candidate will be responsible for...

  • Chemistry and Manufacturing Control Expert

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Key ResponsibilitiesYour main objectives as a Senior QP delegate in our CMC API QA team will be to ensure that all API released for clinical trials meet the highest quality standards, participate in regulatory inspections and audits, and ensure compliance with cGMP and other regulatory requirements. Additionally, you will work closely with colleagues to...

  • QA Specialist for Validation

    2 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Would you like to play an important role in ensuring the quality and safety of products for clinical trials, where you can use your solid QA and validation experience in a project context? Then we can offer you a unique position with a lot of responsibility and impact in a dynamic...

  • Senior QA Specialist for Regulatory Compliance

    2 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled and experienced QA Specialist to join our team in Clinical Trials. As a member of our Quality Assurance department, you will play a crucial role in ensuring the quality and safety of products for clinical trials. In this dynamic environment, you will work closely with our team of experts to deliver best-in-class...

  • Director of Regulatory Affairs for CMC Biologics

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Director of Regulatory Affairs for CMC Biologics & Rare Diseases Category: Project Management & Agile Location: Søborg, Capital Region of Denmark, DK Are you an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs? Do you excel in a dynamic environment and want to be part of a rapidly...

  • Senior QA Professional

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Are you passionate about quality, business understanding and communication with many stakeholders across the company? Do you want to shape the future of your area? If so, this is a unique opportunity, where you will be responsible for a broad area with many diverse stakeholders - apply nowThe positionThe position covers QA oversight and support for...

  • QA Professional

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Are you passionate about quality, business understanding and communication with many stakeholders across the company? Do you want to shape the future of your area? If so, this is a unique opportunity, where you will be responsible for a broad area with many diverse stakeholders - apply nowThe PositionThe position covers QA oversight and support for...

  • Senior QA Professional, Integrated Quality

    6 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Senior QA Professional, Integrated Quality & Staffs Category: Quality Location: Søborg, Capital Region of Denmark, DK Are you passionate about quality, business understanding and communication with many stakeholders across the company? Do you want to shape the future of your area? If so, this is a...

  • Regulatory Affairs Director

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job Description:We are seeking an experienced leader to join our team as the Director of Regulatory Affairs for CMC Biologics and Rare Diseases. As a key member of our leadership team, you will play a pivotal role in shaping the future of RA CMC. Your expertise in drug regulatory affairs will drive excellence in our pipeline and deliver regulatory approvals...

  • Advanced QA for External Production at CMO

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Advanced QA for External Production at CMO Category: Quality Location: Søborg, Capital Region of Denmark, DK Do you want to work in one of the most interesting and challenging areas in Novo Nordisk? Are you passionate about Quality Assurance and Quality Management Systems (QMS)? Are you eager to...

  • Senior IT/OT Solution Manager

    6 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Bagsværd, Denmark Jobkategori Digital & IT Do you want to be part of our ambitious journey to digitise and automate the processes in our API Pilot factories, where the insulin and GLP-1's of the future are being developed? Are you motivated to lead the design, implementation, and management of IT/OT solutions to enhance...

  • Senior Quality Assurance Specialist

    6 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    At Novo Nordisk, we're seeking a highly skilled Senior Quality Assurance Specialist to join our Digital Health & Staffs Quality (DHSQ) department. This is an exciting opportunity for someone with a passion for quality and process improvements.The successful candidate will be responsible for overseeing quality and optimizing processes within Digital Health,...

  • Senior Quality Assurance Specialist

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Our company, Novo Nordisk A/S, is a leader in the pharmaceutical industry. We are seeking a highly skilled and experienced Senior QA Professional to join our team.The ideal candidate will have a strong background in quality assurance, regulatory compliance, and process improvement. The role will involve providing expert guidance on quality management...

  • Automation Systems Specialist

    6 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    As a key member of the Novo Nordisk PSQIT organisation, you will be part of Chemistry, Manufacturing and Control (CMC) Development & Scaling. Our team makes a real difference for patients with chronic diseases across the world by developing, manufacturing and distributing drug candidates for clinical trials.We are looking for an Automation Systems Specialist...

  • AVEVA PI Engineer

    6 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Do you want to play a key role in establishing and developing our data foundation and thereby make a difference for patients by transforming the approach of innovative research? Now is your opportunity to join a fun and diverse team working to bring our area vision of fast access to all CMC information through connected solutions and futureproof scalable &...

  • Material Management Lead

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    We are AGC Biologics, a leading Contract Development Manufacturing Organization (CDMO) dedicated to delivering high-quality biologics manufacturing services. Our team is comprised of experts in quality assurance, process development, and analytical sciences.We are seeking a skilled QA professional to lead our Material Management team. In this role, you will...

  • Quality Assurance Expert

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Welcome to AGC Biologics, a global Contract Development Manufacturing Organization (CDMO) providing comprehensive services from DNA to active pharmaceutical ingredient (API). Our company culture is built around collaboration, innovation, and a commitment to excellence.We seek an experienced QA professional to lead our Material Management team. This key role...

  • Biologics Manufacturing Specialist

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    At AGC Biologics, our purpose is to bring hope to life by enabling life-changing therapies for patients worldwide. We create a healthier and happier tomorrow by working side by side with our customers to improve patients' lives through new biopharmaceuticals.We are seeking an experienced QA scientist to assist with Quality Assurance of Material Management....

  • Senior Procurement Leader

    3 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Alba Project Group ApS Full time

    At ALBA Project Group ApS, we are seeking a motivated Senior Procurement Manager to join our team. As a key member of our organization, you will play a crucial role in delivering high-quality CAPEX procurement services to our clients.About UsWe are a fast-growing consultancy company with extensive experience in project management disciplines and procurement...

  • Senior Procurement Manager

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Alba Project Group ApS Full time

    We are looking for a permanent employee to take up the position as Senior Procurement Manager (+7 years) to support our clients' needs in handling CAPEX contracts. Our typical clients are large pharma or biopharma producers that are expanding their production facilities. Must be on site in Copenhagen, Denmark. Job Description Join our passion of becoming the...