Early project QA Lead for Capacity Expansion Portfolio

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Would you like to be part of expanding our capacities to support the company portfolio of future oral and injectable pharmaceuticals? Are you excited at the prospect of designing new projects to shape the way we assure quality? Ready to make your part to bring new innovative treatments to patients worldwide? If yes, read more and apply now! The position [xxxxx] is establishing new, ground-breaking biotech facilities utilising modern technology with fully automated operations and digitalised processes; they will be situated in Denmark and abroad and must be designed in accordance with GMP requirements (Good Manufacturing Practice) and upon maturing of the projects, you will take part in a successful handover to the local project QA organisation. As Early project QA Lead, you will be responsible for maturing the QA/validation scope within [xxxxx] Capacity Expansion projects by:

Setting direction on current and future GMP expectations

Building quality and validation foundation for project execution

Facilitating a smooth handover to project organisation

Building strong relations to internal competences and line of business

You will be connected to one or more investment projects, where your deep knowledge will come into play, when designing solutions for new facilities, starting from the very early phases, and continuing all the way through to final validation and transferring the facilities into operation.
Qualifications This role will have you be at the centre of leading and decision making in a high complexity landscape for building and then develop and maintain new facilities, for this reason the ideal candidate has a robust personality, is good at building relations and creating trust and is able to proactively set clear direction within the quality agenda. To succeed in this role, you:

Hold a Master’s degree within science or equivalent

Have extensive experience within QA, validation or production capacity expansions roles

Have gained said experience from the pharmaceutical industry

Have solid communication skills

Full English proficiency

Experience from project management or project execution will be seen as an advantage, especially in big construction projects. Experience within the fields of Validation, Quality Risk Management & Risk Processes and Design & Implementation is a big plus. On a personal level, you enjoy close teamwork, are a strong motivator of others and can stay balanced, when the waves get high. You thrive in a multicultural environment working across organisational borders and management levels. Building structures comes naturally to you and you enjoy simplifying wherever simplicity can benefit reaching the goals fast and in a sound and solid manner. About the department Investment Portfolio QA Support works to quality assure compliance to GMP in capacity expansion projects by early involvement in the project portfolio in [xxxxx]. Through our responsibility and collaboration with project organisations and stakeholders, we set direction for future cGMP compliance and oversee quality in facility design and construction. Ultimately this facilitates inspection readiness delivering highest quality products to patients. The department works across all [xxxxx] sites as proximity to the projects is important. Currently the department consists of 25 good colleagues working across all [xxxxx] sites and processes. Working at [xxxxx] At [xxxxx], 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  If you require further information, please call Morten Skov Nørgaard on +[xxxxx]     Deadline 16 March 2025   You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your 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 [xxxxx] 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.

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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 16.12.2024, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.

Type: Øvrige
Sted: Bagsværd

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