Senior Quality Validation Specialist
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Gentofte
Do you want to play a crucial role in setting strategic direction within validation strategy for breakthrough therapy of our development products? Would you like to cooperate with some of our most experienced process experts, managers, and other stakeholders?
Then you might be the right fit to join our colleagues in Biotech & Rare Diseases Quality Assurance (BRD QA) in Gentofte.
Read more and apply!
The position
In Novo Nordisk we are driving innovation to discover new medicines to transform the way we treat people living with a rare disease. An accelerated approaches are most suitable for breakthrough therapies against serious diseases with no or very limited treatment options. As Senior QA Specialist your key task is to set direction for the process validation strategy for a wide range of new products and technologies that currently are entering BRD. We seek knowledge of Process Validation and breakthrough therapy to assist our department within QA of the Manufacturing Development (Mdev) Area.
On a regular basis you can expect to:
• Set the direction for process validation of the full value chain including breakthrough therapy strategies in line with authority expectations.
• Act as a validation Subject Matter Expert, ensuring a data driven, science, and risk-based validation approach on defining process strategy for major projects
• Support and provide guidance to the BRD QA management team
• Be involved in submission of documents to the authorities
• Be responsible to collect branch knowledge and benchmarking validation to Novo Nordisk
This role will enable you to make an impact of subject matter expertise in the entire process from the introduction of a product till its submission and to have organisational influence challenging and setting direction for processes across BRD & BRD QA.
You will be required to utilize your stakeholder management skillset, cultural understanding and build a strong understanding of the company.
Qualifications
In your role you take responsibility, work independently, and make decisions that balance quality demands, authority expectations, and business needs.
To succeed you:
• Hold a master’s degree or PhD within Engineering, Pharmacy, or similar
• Have proven experience with process validation for breakthrough products in the pharmaceutical industry
• Have strong GMP knowledge and are able to increase simplicity in the processes
• Are proficient in English
Previous experience from scoping, planning, driving, and executing validation projects will be seen as an advantage as well as familiarity with collaborating with CMO (Contract Manufacturing Organizations) and vendors working with breakthrough and/or rare disease therapies.
Finally, you have a flair for stakeholder management and networking at various organisational levels, also showing you strong communication skills that can create fellowship in the organisation.
About the Department
You will become a part of the department “BRDQA for QC (Quality Control), MDev & Support”, which is a dynamic and well-functioning department with many interfaces and stakeholders around the organization. The department counts 30 employees and consists of three teams.
The teams are supporting and overseeing QC laboratories, support functions to production and product life cycle, and are highly involved in the core of quality processes and authority inspections.
As a Validation Specialist you will be referring directly to the Quality director, and you will join a department of highly skilled and experienced colleagues. The teams have a high level of self-governance, and the working relations are informal. We value good humour and an open and honest culture. We appreciate a colleague who takes responsibility, has a positive and curious approach to new challenges and contributes to a pleasant working atmosphere. We have a high focus on a great work-life balance, with the flexibility to work from the office and remote.
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 Tanja Thorskov Bladt +45 3075 5155
Deadline
31 December 2022
Please note that interviewing may start prior to deadline, so don’t hesitate to submit your application as soon as possible.
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.
Print job Send to e-mail
Then you might be the right fit to join our colleagues in Biotech & Rare Diseases Quality Assurance (BRD QA) in Gentofte.
Read more and apply!
The position
In Novo Nordisk we are driving innovation to discover new medicines to transform the way we treat people living with a rare disease. An accelerated approaches are most suitable for breakthrough therapies against serious diseases with no or very limited treatment options. As Senior QA Specialist your key task is to set direction for the process validation strategy for a wide range of new products and technologies that currently are entering BRD. We seek knowledge of Process Validation and breakthrough therapy to assist our department within QA of the Manufacturing Development (Mdev) Area.
On a regular basis you can expect to:
• Set the direction for process validation of the full value chain including breakthrough therapy strategies in line with authority expectations.
• Act as a validation Subject Matter Expert, ensuring a data driven, science, and risk-based validation approach on defining process strategy for major projects
• Support and provide guidance to the BRD QA management team
• Be involved in submission of documents to the authorities
• Be responsible to collect branch knowledge and benchmarking validation to Novo Nordisk
This role will enable you to make an impact of subject matter expertise in the entire process from the introduction of a product till its submission and to have organisational influence challenging and setting direction for processes across BRD & BRD QA.
You will be required to utilize your stakeholder management skillset, cultural understanding and build a strong understanding of the company.
Qualifications
In your role you take responsibility, work independently, and make decisions that balance quality demands, authority expectations, and business needs.
To succeed you:
• Hold a master’s degree or PhD within Engineering, Pharmacy, or similar
• Have proven experience with process validation for breakthrough products in the pharmaceutical industry
• Have strong GMP knowledge and are able to increase simplicity in the processes
• Are proficient in English
Previous experience from scoping, planning, driving, and executing validation projects will be seen as an advantage as well as familiarity with collaborating with CMO (Contract Manufacturing Organizations) and vendors working with breakthrough and/or rare disease therapies.
Finally, you have a flair for stakeholder management and networking at various organisational levels, also showing you strong communication skills that can create fellowship in the organisation.
About the Department
You will become a part of the department “BRDQA for QC (Quality Control), MDev & Support”, which is a dynamic and well-functioning department with many interfaces and stakeholders around the organization. The department counts 30 employees and consists of three teams.
The teams are supporting and overseeing QC laboratories, support functions to production and product life cycle, and are highly involved in the core of quality processes and authority inspections.
As a Validation Specialist you will be referring directly to the Quality director, and you will join a department of highly skilled and experienced colleagues. The teams have a high level of self-governance, and the working relations are informal. We value good humour and an open and honest culture. We appreciate a colleague who takes responsibility, has a positive and curious approach to new challenges and contributes to a pleasant working atmosphere. We have a high focus on a great work-life balance, with the flexibility to work from the office and remote.
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 Tanja Thorskov Bladt +45 3075 5155
Deadline
31 December 2022
Please note that interviewing may start prior to deadline, so don’t hesitate to submit your application as soon as possible.
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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Gentofte.
Jobbet er oprettet på vores service den 29.6.2022, 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.
- Øvrige
- Gentofte
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