Process Improvement Expert - Regulatory Affairs, CMC
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Søborg
We are seeking a highly motivated and skilled Process Improvement Expert to join our Regulatory Affairs (RA) team and drive process improvements within RA CMC & Device. The successful candidate will be responsible for driving and anchoring continuous process improvements, driving initiatives towards PQ/CMC, and ensuring the highest level of efficiency and compliance in all RA CMC processes. If you are an ambitious, process-focused individual with a passion for driving continuous improvement, we encourage you to apply for this exciting opportunity. We offer a competitive salary and benefits package, as well as opportunities for growth and development within our organization. Apply now! The position In this role, you will be at the forefront of driving process improvements within RA CMC & Device, demonstrating a proactive approach to enhance operational efficiency. Your responsibilities will extend to overseeing the implementation of process improvements, ensuring sustained and consistent performance levels. You will take the lead on update, development and implementation of processes and procedures including initiatives related to PQ/CMC. Keeping the process landscape updated will be integral to your role, aligning it with evolving organizational needs and industry best practices. Continuous monitoring and assessment of RA processes will be your focus, identifying areas for improvement and implementing corrective measures. You will also be a key figure in managing deviations and change requests pertinent to RA CMC & Device, serving as a driver for resolution using systematic problem-solving techniques. Collaboration with cross-functional teams will be crucial, allowing for the effective implementation and integration of process improvements across the organization. In addition, you will be responsible for developing and meticulously maintaining clear and precise standard operating procedures (SOPs) that adhere to regulatory requirements. Ensuring unwavering compliance with regulatory requirements and guidelines will be a central aspect of your role. Qualifications We expect that you hold a master’s degree in biotechnology, engineering, pharmacy, regulatory science, or similar scientific area and that you have been working within the regulatory field for at least 5-7 years. However, your educational background may well be overshadowed by your professional background. To excel in this role, you need: Strong LEAN thinking skills with a proven track record of driving process improvements Energized by process improvements and always looking for new and innovative ways to optimize processes Flair for IT systems; experience with Vault RIM is an advantage as our processes are anchored in this system Experience with deviation and change request authoring/handling is an advantage Ability to write clear and precise SOPs; SOP author experience is an advantage Proven track record of training colleagues in new/improved processes The ideal candidate has regulatory CMC hands on experience On a personal level, you have excellent communication and collaboration skills which are fundamental in this role for effective interaction with others. You are self-motivated which signifies an internal drive and initiative to accomplish tasks independently. This quality is complemented by the versatility to seamlessly transition between working independently and collaboratively within a team setting. Finally, you have a strong attention to detail and the ability to work in a fast-paced environment. Fluency in English, encompassing both verbal and written communication, is an essential skill for effective engagement and collaboration with various stakeholders. About the department You will be anchored in RA CMC Biotech & Rare Disease among approx. 40 skilled colleagues dealing with all regulatory CMC aspects on our portfolio of products and projects as well as on our processes. You will serve across RA CMC & Device counting approx. 250 employees sited mainly in Søborg and Bangalore but also including people in Seattle and Chartres. The position will be placed in Søborg, Denmark. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Associate Director, Dorte Lunøe at +45 30790217. Deadline 7 January 2024. We will review applications on an ongoing basis, so we encourage you to apply as soon as possible. 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
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.
- Apoteker
- Søborg
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