Senior GMP Quality Specialist
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Do you want to have a direct impact on the success of acquired companies? Do you wish to ensure quality assessment and deliveries during the Mergers & Acquisition (M&A) transaction phases? If yes, we are currently looking for a GMP Quality Specialist to drive and execute the quality track of due diligences related to M&A activities. Apply now to join our company and be part of a life-changing career! The position
You will be part of Novo Nordisk Quality Due Diligence (DD) & Integration unit and assist in maturing overall M&A transactions capability, in particular due diligence, and act as a quality partner to the wider organisation in the due diligence phase.
As GMP Quality Specialist, your primary role will be to support the Quality organisation in proactively coordinating due diligence activities and perform the needed quality assessment.
Among main tasks you will:
• Drive the Quality DD assessment
• Assessing the Quality level and GMP compliance level of assets during DD
• Participate in internal DD meetings to consolidate and align the Quality position and the integration strategies
• Report the DD recommendations and material for decision making in close collaboration with the different Quality areas in Novo Nordisk
• Review the legal contract and transition agreements referred in the legal contract
• Support handover of DD outputs of acquired companies to the integration team
The job offers interaction across the organisation, allowing you to build a strong network as you will ensure relevant stakeholders are involved and informed, and you will present findings and recommendations to management for endorsement.
Furthermore, you will act as GxP subject matter expert in your core area.
Qualifications
We are looking for an ambitious and proactive colleague who can contribute to the team both professionally and personally. You structured mindset will support you in coordinating teams, while you will combine strategic thinking with a strong quality and business understanding, to conduct and translate complex analysis into clear messaging. To succeed in this role, you have:
• A Master’s degree
• Solid experience with GMP requirements and Chemistry, Manufacturing and Control regulatory requirements (i.e. Drug development, manufacturing)
• Broad experience with QA/QP activities (batch review/release, document review/approval)
• Experience with supplier management
• Full English proficiency It will be seen as an advantage if you have experience in aseptic processes, auditing and DD. Due to our global presence, you should be open to occasionally travel.
On a personal level, you are a strong team player who enjoys delivering on short deadlines, delivering high quality deliverables for senior management and other key stakeholders. You are solution-oriented and have strong analytical and communication skills. About the department
You will become part of a great department with many interfaces around the organisation. The newly established Quality DD area is responsible for establishment and implement an efficient due diligence process in Quality of potential acquisitions within manufacturing capacities and assets. You will have the exciting opportunity to take part in building the organisation and structure, as well as shaping the role we take in the M&A phases.
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 Director Bodil Rindel at +45-30794379
Please note that Bodil will be out of office for Christmas vacation until the 2nd of January – so do not contact prior that date.
Referral
Do you know someone who might be a great fit for this position and is it someone who you would like to have as a colleague? All you need to do is select “'Refer a candidate” on the specific job and your friend will receive an email allowing them to send their official application and be registered as referral.
Deadline
14 January 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 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.
You will be part of Novo Nordisk Quality Due Diligence (DD) & Integration unit and assist in maturing overall M&A transactions capability, in particular due diligence, and act as a quality partner to the wider organisation in the due diligence phase.
As GMP Quality Specialist, your primary role will be to support the Quality organisation in proactively coordinating due diligence activities and perform the needed quality assessment.
Among main tasks you will:
• Drive the Quality DD assessment
• Assessing the Quality level and GMP compliance level of assets during DD
• Participate in internal DD meetings to consolidate and align the Quality position and the integration strategies
• Report the DD recommendations and material for decision making in close collaboration with the different Quality areas in Novo Nordisk
• Review the legal contract and transition agreements referred in the legal contract
• Support handover of DD outputs of acquired companies to the integration team
The job offers interaction across the organisation, allowing you to build a strong network as you will ensure relevant stakeholders are involved and informed, and you will present findings and recommendations to management for endorsement.
Furthermore, you will act as GxP subject matter expert in your core area.
Qualifications
We are looking for an ambitious and proactive colleague who can contribute to the team both professionally and personally. You structured mindset will support you in coordinating teams, while you will combine strategic thinking with a strong quality and business understanding, to conduct and translate complex analysis into clear messaging. To succeed in this role, you have:
• A Master’s degree
• Solid experience with GMP requirements and Chemistry, Manufacturing and Control regulatory requirements (i.e. Drug development, manufacturing)
• Broad experience with QA/QP activities (batch review/release, document review/approval)
• Experience with supplier management
• Full English proficiency It will be seen as an advantage if you have experience in aseptic processes, auditing and DD. Due to our global presence, you should be open to occasionally travel.
On a personal level, you are a strong team player who enjoys delivering on short deadlines, delivering high quality deliverables for senior management and other key stakeholders. You are solution-oriented and have strong analytical and communication skills. About the department
You will become part of a great department with many interfaces around the organisation. The newly established Quality DD area is responsible for establishment and implement an efficient due diligence process in Quality of potential acquisitions within manufacturing capacities and assets. You will have the exciting opportunity to take part in building the organisation and structure, as well as shaping the role we take in the M&A phases.
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 Director Bodil Rindel at +45-30794379
Please note that Bodil will be out of office for Christmas vacation until the 2nd of January – so do not contact prior that date.
Referral
Do you know someone who might be a great fit for this position and is it someone who you would like to have as a colleague? All you need to do is select “'Refer a candidate” on the specific job and your friend will receive an email allowing them to send their official application and be registered as referral.
Deadline
14 January 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 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 22.12.2023, 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.
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