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Senior Manager, MDEV LCM and QC : ET | Manager in Executive Job in Durham NC | 7263844642

This listing was posted on Tip Top Job.

Senior Manager, MDEV LCM and QC : ET

Location:
Durham, NC
Description:

About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes and obesity. Beingpart of Novo Nordisk allows our employees to embark on life:changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies : Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. What we offer you: :Leading pay and annual performance bonus for all positions:All employees enjoy generous paid time off including 14 paid holidays:Health Insurance, Dental Insurance, Vision Insurance : effective day one:Guaranteed 8 401K contribution plus individual company match option:Family Focused Benefits including 12 weeks paid parental and 6 weeks paid family medical leave:Free access to Novo Nordisk:marketed pharmaceutical products:Tuition Assistance:Life and Disability Insurance:Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Establish a satellite team in Manufacturing Development Life Cycle Management (Mdev LCM) in Emerging Technologies (ET) for the production site. Lead strategic activities ensuring new products can thrive without disrupting the production of existing products. Ensure local support and optimization of our solid dosage formulation production in interface with the sites across the world, driving the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions stylemargin:bottom:11.0px::Lead, drive and coach teams to ensure a high performing collaborative team environment, to include providing feedback, structure and accountability to continuously improve team engagement and performance:Drive Mdev LCM and QA requirements at the site ensuring a high level of communication and collaboration with both internal (US and DK based) and external stakeholders:Drive a safe workplace culture, ensuring safety and environmental requirements are met:Maintain plans to meet changes in customer requirements:Ensure processes and roles are established and capable to meet quality specifications and requirements, to include GMP Compliance of the team:Ensure appropriate support is on site as needed during production activities:Coordinate all validation/transfer activities involving MDev support:Lead team in successful execution of support to the productions:Coordinate with Director, Bulk, Pack, QC and EM and other teams on workload issues and priorities:Coordinate and be on track with the VP plans for production at the site:Frequent planning to ensure resources are in place to execute the plan:Ensure tracking and reporting of KPI's:Ensure knowledge transfer and alignment with LCM department, MDEV DK and all other relevant stakeholders:Ensure department documents are current and standardized:Support training and development of LCM personnel:Provide guidance for and approval of Investigations and deviations:Build the department's competence house and the supporting training principles:Ensure implementation of cLEAN(R) principles in the team:Follow all safety and environmental requirements in the performance of duties:Other accountabilities, as assigned
Industry:
Insurance
Posted:
May 8 on Tip Top Job
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