Novo Nordisk
Global Contract Manufacturing QA Manager for QC
Can you picture yourself at the forefront of Quality Assurance in Contract Manufacturing Organizations (CMO) Drug Substance focusing on QC? Are you up for the challenge of driving leadership and team development to meet evolving business demands?
Imagine the thrill of making independent decisions on the international stage and shaping the future of excelling in external manufacturing. Join our company and be part of a life-changing career!
The position
As a Manager in Global Contract Manufacturing Quality Assurance – Drug Substance (GCM QA DS), you will drive Quality Assurance for our QC team. The team is responsible for QC oversight and approval of QC validations at our CMOs. Collaboration between our Project and Operational teams and with the Analytical Coordinators is key to be successful.
Your main responsibilities will be to:
Drive leadership & team development to ensure continuous team/people development to fulfil business demands
Proactively manage QA resources to secure both QC oversight and approval of QC documentation
Ensure that our processes are continuously improved
Proactively seek close collaboration with internal and external key stakeholders to ensure alignment on external requirements, QMS, business need and resources
This role will give you a high degree of ability to make independent decisions that will represent Novo Nordisk in an international context under sometimes challenging conditions due to cultural, national or political restrictions when operating. Due to the international nature of the job, you will have the opportunity to travel to CMO partners globally.
Qualifications
The candidate we are looking for is able to manage both the quality requirements and business perspective, with an ability to balance quality, delivery and cost efficiency.
To succeed in this role, you:
Hold a master’s degree in pharmacy, Engineering, Biochemistry or similar
Have experience in a GMP regulated environment preferably from QC
Have gained experience from working at a CMO or within Quality Assurance
Have proven experience in being a leader
Are fluent in English, both written and spoken
On a personal level, you proactively challenge problems, remove obstacles and take decisions to ensure execution, seek influence and stay firm when needed to secure the quality and compliance aspects. Clear communication will be key, as well as the ability to demonstrate authority but also trust – as you demonstrate personal integrity, Global Contract Manufacturing QA – Drug Substance (GCM QA - DS) are responsible for product quality and QA & QC Oversight of CMOs and the final batch release of batches produced externally.
About the Departament
At the moment the Area consists of 45 highly qualified employees in 7 different teams, but we are growing very fast and expecting to become bigger in the near future. From January we will be located in Høje Tåstrup.
We are working in an international environment with many different companies and stakeholders with engagement, trust and mutual respect. Our performance is driven by the right behavioral and a wish to think big, improve and simplify our way of working while ensuring quality compliance, product quality and patient safety.
capability and maturity in personal conduct.
Your leadership style is collaborative and inclusive, and you have the ability to listen, coach and motivate employees to deliver their best – engaging them in taking pride when meeting their objectives.
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