Country Quality Manager

6 days ago


København, Denmark Novartis Farmacéutica Full time
Country Quality Manager - Qualified Person, Responsible Person

Job ID REQ-10035063

Jan 10, 2025

Summary

The Country Quality Manager - QP, RP is responsible for the assurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. The Country Quality Manager ensures that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP. The Country Quality Manager acts as the Responsible Person (RP) for Novartis Healthcare A/S, Denmark and as the Qualified Person (QP) for Novartis Country legal Novartis Healthcare A/S, Denmark, ensuring that Novartis operates in compliance with any applicable regulations (GMP & GDP).

About the Role

Major accountabilities:

  1. Act as the Responsible Person, RP, for all requests related to Novartis Healthcare A/S GDP activities
  2. Ensure compliance with and implementation of EU GDP and local GDP regulations
  3. Responsible for the import control of medicinal products imported with the wholesaler license of Novartis Country legal entity
  4. Coordinating and promptly performing any recall and mock recalls for medicinal products
  5. Act as the Qualified Person for Novartis Healthcare A/S
  6. Assure local compliance with and implementation of EU GMP and local GMP regulations
  7. Ensure QP approval of local manufacturing activities performed during the importation of medicines from third countries
  8. Release commercial medicines for distribution after QP certification

Qualifications:

  1. Masters Degree in Pharmacy or related Life Science fields.
  2. Eligible to be approved as Responsible Person by local Health Authority for WDA license. Eligible to act as Qualified Person (QP). EU QP qualifications must be effective and recognized by local regulations.
  3. 5+ years of experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, clinical development or production or a directly related area.
  4. Solid GxP knowledge.
  5. Quality mindset, analytical approach, self-driven and collaborative.
  6. Fluent English, written and spoken. Knowledge of Danish is highly preferred.

Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

DK06 (FCRS = DK006) Novartis Healthcare A/S

Functional Area Quality

Job Type Full time

Employment Type Regular

Shift Work No

#J-18808-Ljbffr

  • København, Denmark Healthcare Businesswomen’s Association Full time

    Job Description Summary Location: Hybrid, Denmark The Country Medical Director is the lead medical representative for the country and has a strategic leadership role ultimately responsible for overseeing the medical function in a country. This role is responsible for driving medical excellence and ensuring that the country medical affairs part of the...


  • København, Denmark IT Minds Full time

    Req ID:461747 At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than colleagues lead the way to greener and smarter...


  • København, Denmark Alstom Transport Danmark AS Full time

    Location: Copenhagen, DK Company: Alstom Req ID:461747 At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than 80,000...


  • København, Denmark Corti Full time

    There is no quality healthcare without a quality dialogue. Today, that dialogue is broken; we need you to help us fix it. Doctors and nurses across the world are facing unprecedented challenges. When we meet them, they're dealing with heavy workloads, extensive paperwork, and the pressure of performing well, which in healthcare, can have dire consequences....


  • København, Denmark Lundbeck AS, H Full time

    Press Tab to Move to Skip to Content Link Training manager, IT Quality & Compliance Requistion ID:  5574 Location:  Copenhagen, Danish Capital Region, DK Training manager, IT Quality & Compliance  Are you a visionary Training Manager with an enthusiasm for innovation and do you want to revolutionize how training is conducted? We are...


  • København, Denmark H. Lundbeck AS Full time

    Are you a visionary Training Manager with an enthusiasm for innovation and do you want to revolutionize how training is conducted? We are looking for someone who thinks beyond the standard of SOPs and can infuse creativity into both GXP and non-GXP training programs for our colleagues consisting of specialists within their field. If you’re ready to...


  • København, Denmark Veo Technologies Full time

    Copenhagen Builders – Capture / Full Time / On-site Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We’re democratizing the world of sports by granting video analysis for teams on all levels—a privilege...


  • København, Denmark Conference Manager Full time

    About the role As Sales Development Representative, your daily mission is to identify and contact potential customers, create interest in Conference Manager and book meetings for our Sales Manager in Denmark. Reporting to and working closely with the Sales Manager, this is your chance to gain valuable experience in complex SaaS sales, work with a proven...


  • København, Denmark Swedavia AB Full time

    Quality Engineer to Engine Lifecycle Management Are you ready to be part of the world's leading company in marine engines and solutions and are you passionate about quality? MAN Energy Solutions is on the lookout for a talented Quality Engineer to make a difference. You will play an important role in: Be the key player in first-time production approval for...


  • København, Denmark The HubDanske Bank Full time

    Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We’re democratizing the world of sports by granting video analysis for teams on all levels—a privilege that used to be only for the few. More than 40,000 clubs...


  • København, Denmark Veo Technologies Full time

    Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We’re democratizing the world of sports by granting video analysis for teams on all levels—a privilege that used to be only for the few. More than 40,000 clubs...


  • København, Denmark Veo group Full time

    Veo is a global leader in AI-based sports camera technology. Our innovative, fully automatic camera solution enables sports teams to record matches and training sessions without a camera operator. We’re democratizing the world of sports by granting video analysis for teams on all levels—a privilege that used to be only for the few. More than 40,000 clubs...

  • Director, Quality

    1 day ago


    København, Denmark National Oilwell Varco Denmark IS Full time

    Director, Quality Overview We are a leading engineering and manufacturing company specializing in subsea production systems for the oil and gas and industrial sectors. With a commitment to innovation, sustainability, and operational excellence, we provide energy solutions to our clients worldwide. Our dedication to quality is at the forefront of our...

  • Country Lead

    6 days ago


    København, Denmark Learningbank Full time

    Meet Learningbank We’re a dynamic Danish scale-up with over 35 dedicated Learningbankers. We’ve developed the world’s first Learning Lifecycle Platform, designed to help deskless workforces create and distribute engaging digital learning. As we rapidly expand across Denmark, the Nordics, and Europe, we’re excited to partner with top names like...


  • København, Denmark Globalnyt Full time

    Here is a rare opportunity to take a primary role within ActionAid Denmark’s donor engagement. Are you looking for the next step in an already well-established professional journey within international development and donor portfolio management? The team International Programmes and Partnerships (IPP) is the team in AADK (ActionAid Denmark) international...


  • København, Denmark ActionAid Denmark Full time

    Here is a rare opportunity to take a primary role within ActionAid Denmark’s donor engagement. Are you looking for the next step in an already well-established professional journey within international development and donor portfolio management? The team International Programmes and Partnerships (IPP) is the team in AADK (ActionAid Denmark) international...


  • København, Denmark NKT AS Full time

    Category: Quality & Safety Location: Chennai, IN NKT connects a greener world with high-quality power cable technology and takes centre stage as the world moves towards green energy. We design, manufacture and install low-, medium- and high-voltage power cable solutions enabling sustainable energy transmission. Do you want to be a part of the change against...


  • København, Denmark Lundbeck AS, H Full time

    Quality Assurance Professional, Quality Assurance Requisition ID: 5620 Location: Copenhagen, Danish Capital Region, DK Quality Assurance Professional, Quality Assurance Are you eager to apply your strong quality mindset in strengthening Lundbeck’s commercial manufacturing and distribution processes? Are you motivated by influencing the way we work with...


  • København, Denmark H. Lundbeck AS Full time

    Are you eager to apply your strong quality mindset in strengthening Lundbeck’s commercial manufacturing and distribution processes? Are you motivated by influencing the way we work with compliance and quality in Lundbeck? We are looking for an experienced QA Professional who can join our highly skilled team in Lundbeck. Your new role We offer you an...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...