Senior QA Professional (local manufacturing CMO projects)
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Nordsjælland
Are you an experienced Quality Assurance professional with expertise in manufactur-ing equipment/facility qualification and process validation? Do you want to expand our CMO (Contract Manufacturing Organisation) business internationally and make a dif-ference for millions of patients?
If so, this is a great and impactful opportunity to advance your career in one of the most challenging areas at This is a fantastic opportunity to join a time of LCMO where new business areas are established. Read more and apply for a life-changing career with us today! The position
With this important role, you will join a highly skilled QA team responsible for ensur-ing quality and progress in our global project portfolio. We are currently in LCMO bringing in new CMO-s to produce insulin products for millions of patients globally. You will be involved and take lead in all project phases such as due diligence, estab-lishing good collaboration with CMO-s, technology transfer, equipment/facility qualifi-cation, process validation. You will:
• Lead QA efforts in market and capacity expansion projects, setting quality and compliance directions.
• Ensure QA oversight, GMP compliance, and project progress throughout all phases and oversee project execution with ambitious timelines, including fre-quent visits to CMO-s.
• Set the quality direction and approve documents for equipment and facility qualification, as well as production line validation including Aseptic, QC and packaging.
• Foster collaboration with CMO-s, build a quality mindset, and promote a culture of compliance.
• Train and mentor local CMO-s QA organisations to maintain and improve com-pliant operations. Travel: As the CMO-s are located outside Denmark, and you will be responsible for onsite activities at the CMO, you should expect travel of up to 1 month of per year, visiting the CMO-s with potential for more in the first year. Qualifications
We are looking for someone with:
• An M.Sc. in Pharmacy, Chemistry, Biotechnology Engineering, Science, or a similar field.
• At least 6 years of relevant experience in QA within pharmaceutical manufacturing, preferably in aseptic, assembly, or packaging production.
• Strong knowledge and experience in EU GMP requirements, Quality Assurance, Quality Management Systems (QMS), and the qualification and validation of equipment and facilities.
• Experience and very good skills in stakeholder management and collaboration in an international environment.
On a personal level, your very good stakeholder management skills, high energy, open-mindedness, and positive attitude will be instrumental to deliver the projects. You should possess strong cross-functional skills and the ability to engage and ener-gize local employees at the CMO-s. Fluency in English is required, and knowledge of other languages is an advantage. Your capability to manage high-level tasks in a cul-turally diverse in an international and potentially politically challenging environment and effectively collaborate with local employees at CMOs will be crucial for success in this role. We expect you to be able to handle situations independently, apply your subject matter knowledge, identify better practice, create improvements to processes, share knowledge and to let your colleagues learn and shine.
About the department The position will be part of the Global Contract Manufacturing Drug Products (GCM DP) QA Projects team. LCMO QA is a part of GCM DP QA, A/S. The GCM DP QA Projects LCMO team consist of 7 colleagues located in the Denmark, all working closely together. We cover the CMO locations in Saudi Arabia, India, Bangladesh, and South Africa and we are currently exploring opportunities in other countries. The team is responsible for Quality Assurance of ’s local manufacturing CMO-s. One of the primary roles of QA Projects LCMO is to deliver QA support and set direction for CMO-s in countries where local presence is required to maintain market access.
The job is based in Taastrup, Denmark. Things move fast in our unit, and the daily operation is dependent on cooperation with many internal and external stakeholders from all over the world. Working at At , you will have the opportunity to build a life-changing career in a global business environment. From research and development, to manufacturing, marketing, and sales, we strive to improve quality of life for more than 400 million people living with diabetes or other diseases. Contact
For further information, please contact Abdu Sahan, QA Manager at +. Deadline
09 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.
If so, this is a great and impactful opportunity to advance your career in one of the most challenging areas at This is a fantastic opportunity to join a time of LCMO where new business areas are established. Read more and apply for a life-changing career with us today! The position
With this important role, you will join a highly skilled QA team responsible for ensur-ing quality and progress in our global project portfolio. We are currently in LCMO bringing in new CMO-s to produce insulin products for millions of patients globally. You will be involved and take lead in all project phases such as due diligence, estab-lishing good collaboration with CMO-s, technology transfer, equipment/facility qualifi-cation, process validation. You will:
• Lead QA efforts in market and capacity expansion projects, setting quality and compliance directions.
• Ensure QA oversight, GMP compliance, and project progress throughout all phases and oversee project execution with ambitious timelines, including fre-quent visits to CMO-s.
• Set the quality direction and approve documents for equipment and facility qualification, as well as production line validation including Aseptic, QC and packaging.
• Foster collaboration with CMO-s, build a quality mindset, and promote a culture of compliance.
• Train and mentor local CMO-s QA organisations to maintain and improve com-pliant operations. Travel: As the CMO-s are located outside Denmark, and you will be responsible for onsite activities at the CMO, you should expect travel of up to 1 month of per year, visiting the CMO-s with potential for more in the first year. Qualifications
We are looking for someone with:
• An M.Sc. in Pharmacy, Chemistry, Biotechnology Engineering, Science, or a similar field.
• At least 6 years of relevant experience in QA within pharmaceutical manufacturing, preferably in aseptic, assembly, or packaging production.
• Strong knowledge and experience in EU GMP requirements, Quality Assurance, Quality Management Systems (QMS), and the qualification and validation of equipment and facilities.
• Experience and very good skills in stakeholder management and collaboration in an international environment.
On a personal level, your very good stakeholder management skills, high energy, open-mindedness, and positive attitude will be instrumental to deliver the projects. You should possess strong cross-functional skills and the ability to engage and ener-gize local employees at the CMO-s. Fluency in English is required, and knowledge of other languages is an advantage. Your capability to manage high-level tasks in a cul-turally diverse in an international and potentially politically challenging environment and effectively collaborate with local employees at CMOs will be crucial for success in this role. We expect you to be able to handle situations independently, apply your subject matter knowledge, identify better practice, create improvements to processes, share knowledge and to let your colleagues learn and shine.
About the department The position will be part of the Global Contract Manufacturing Drug Products (GCM DP) QA Projects team. LCMO QA is a part of GCM DP QA, A/S. The GCM DP QA Projects LCMO team consist of 7 colleagues located in the Denmark, all working closely together. We cover the CMO locations in Saudi Arabia, India, Bangladesh, and South Africa and we are currently exploring opportunities in other countries. The team is responsible for Quality Assurance of ’s local manufacturing CMO-s. One of the primary roles of QA Projects LCMO is to deliver QA support and set direction for CMO-s in countries where local presence is required to maintain market access.
The job is based in Taastrup, Denmark. Things move fast in our unit, and the daily operation is dependent on cooperation with many internal and external stakeholders from all over the world. Working at At , you will have the opportunity to build a life-changing career in a global business environment. From research and development, to manufacturing, marketing, and sales, we strive to improve quality of life for more than 400 million people living with diabetes or other diseases. Contact
For further information, please contact Abdu Sahan, QA Manager at +. Deadline
09 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Nordsjælland
Jobbet er oprettet på vores service den 21.2.2025, 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.
- Øvrige
- Nordsjælland
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