Lead Auditor Pharmacovigilance, Global Quality

1 week ago


Hørsholm, Denmark ALK-Abelló AS Full time

Are you an experienced Lead Auditor passionate about audits and Pharmacovigilance (PV)? Do you get energy from working globally in close collaboration with many different cultures? And would you like to be part of ALK and make a difference for people with Allergy?

We are looking for a new colleague for this exiting position, where you are located in the ALK Headquarter in Hørsholm Denmark with the world as your workplace.

The position
We are searching for a full time Pharmacovigilance auditor, responsible for performing PV audits internally at the ALK Headquarter and ALK Affiliates as audits of external collaborators, service providers and distributors. Around 5 travelling days a month is expected.

As Lead Auditor you will become part of the Global Quality function located in ALK Headquarters in Hørsholm, Denmark as member of a committed, enthusiastic and experienced team working with many different QA tasks, processes and systems within different GxP areas.

Your primary responsibility areas and tasks will be:

  • Performing PV audits as Lead auditor, on your own, and in collaboration with other PV and GDP Lead Auditors in ALK.
  • Planning, execution, reporting, and CAPA follow up.
  • Supplier Management, qualification of external collaborators, service providers and distributors.

Your profile
We expect that you have the following qualifications:

  • Experience as Lead Auditor within PV performing internal audits and audits of external collaborators (distributors and service providers) and ability to start directly in a PV Lead Auditor position.
  • B.Sc. / M.Sc. in Health Science with 5+ years of experience within pharmacovigilance regulated areas. including experience with quality management systems and tools.
  • Experience with audits within other GxP area is an advantage.

Personal characteristics:

  • Strong drive takes own initiatives and proactive action.
  • Ability to work independently, but also a strong team player.
  • Relation builder working respectfully across different cultures with flexibility.
  • Excellent in verbal and written communication in Danish and English.
  • Strong cross-cultural communication skills verbally as well as written.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 10 September 2024.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at . For further information regarding the position, please contact Senior Director Global Quality, Siren Jenssen Østerberg at +45 50 89 95 40.

We are looking forward to hearing from you

#J-18808-Ljbffr

  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

    Join ALK-Abello's Global Quality Team as a Pharmacovigilance Lead AuditorWe are looking for an experienced Pharmacovigilance Lead Auditor to join our team in Hørsholm, Denmark. As a member of the Global Quality function, you will be responsible for performing PV audits internally and externally, planning, execution, reporting, and CAPA follow-up.The ideal...


  • Hørsholm, Denmark ALK-Abello Full time

    Are you an experienced Lead Auditor passionate about audits and Pharmacovigilance (PV)? Do you get energy from working globally in close collaboration with many different cultures? And would you like to be part of ALK and make a difference for people with Allergy? We are looking for a new colleague for this exciting position, located in the ALK Headquarters...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

    About the RoleWe are seeking a seasoned Pharmacovigilance Lead Auditor to join our Global Quality team at ALK-Abello. As a key member of our quality assurance function, you will be responsible for conducting internal and external audits, ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesPerforming PV audits as Lead...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

    At ALK-Abello, we are seeking an experienced Lead Auditor to join our Global Quality team. This role will be responsible for performing Pharmacovigilance audits internally at our headquarters and affiliates, as well as audits of external collaborators, service providers, and distributors.About the RoleWe offer a competitive salary in the range of $120,000 -...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    We are seeking a highly skilled Senior Pharmacovigilance Auditor to join our Global Quality team in Hørsholm, Denmark. As a key member of our team, you will play a vital role in ensuring the quality and integrity of our pharmacovigilance processes.About the RoleAs a Senior Pharmacovigilance Auditor, you will be responsible for performing audits of internal...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    We are seeking an experienced Lead Auditor to join our Global Quality team in Hørsholm, Denmark. As a Pharmacovigilance auditor, you will be responsible for performing audits of internal processes and external collaborators, service providers, and distributors. The position involves approximately 5 travelling days per month.The successful candidate will...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

    About the RoleThe Senior Clinical Reporting Lead will lead a team of 7 dedicated employees and be responsible for the global medical writing and clinical reporting function. As part of the Clinical Data Science management team, this role will ensure the fulfillment of Global Clinical Reporting commitments and contribute to a positive working environment with...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

    StillingsbeskrivelseVi søger en erfaren ledelsesperson til stillingen som Quality Assurance Lead for Analytics. I denne rolle vil du lede et team af dygtige medarbejdere og sikre, at vi leverer høj kvalitet i vores analyser.Som Quality Assurance Lead for Analytics er det din opgave at sikre, at vores analyser overstår de højest sete krav til kvalitet. Du...


  • Hørsholm, Hørsholm Kommune, Denmark Veluxpolska Full time

    Headquartered in Hørsholm, north of Copenhagen, The VELUX Group is the world leader in roof windows and skylights.We are family and foundation owned with a long history of great results, and this is your unique opportunity to really impact our performance when it comes to energy management on a global scale.The estimated salary for this role is between...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    About ALK-Abelló A/SALK-Abelló A/S is a leading pharmaceutical company specializing in allergy immunotherapy. We offer a dynamic work environment that fosters personal and professional growth.We are committed to delivering innovative solutions for patients with allergies, and our team is passionate about making a difference in the lives of those...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    Job DescriptionWe are seeking a highly skilled Global Quality Assurance Manager to join our team at ALK-Abelló A/S. As a key member of our Global Quality function, you will be responsible for ensuring the quality and compliance of our pharmaceutical operations worldwide.Responsibilities:Quality Oversight: Proactively develop and improve business processes...


  • Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    Are you interested in working with Marketing Authorisation responsibilities and be involved in both GMP and GDP related topics? Do you get energy from working globally in close collaboration with many different cultures? And would you like to be part of ALK and make a difference for people with Allergy? We are looking for a full-time QA Compliance...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

    Leadership Opportunity in Global Clinical ReportingYou will lead a team of 7 dedicated employees as Director for Clinical Reporting, overseeing the global medical writing and clinical reporting function.Your Responsibilities Will Include:Management of the Clinical Reporting team, ensuring alignment with key stakeholders and optimal resource allocation to...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    Director for Clinical ReportingA challenging leadership opportunity awaits a seasoned professional with expertise in medical writing and team management. As Director for Clinical Reporting, you will be responsible for leading a dedicated team of 7 employees and overseeing the global medical writing and clinical reporting function.The role involves taking a...


  • Hørsholm, Hørsholm Kommune, Denmark Velux Group Full time

    Sustainability Role at Velux GroupThe Velux Group seeks a skilled Biodiversity Sustainability Professional to lead global operations in support of our sustainability goals. This role is a key part of our External Relations and Sustainability department, reporting directly to the Senior Director of Group Sustainability.In this position, you will work closely...


  • Hørsholm, Hørsholm Kommune, Denmark VELUX Group Full time

    About the RoleWe are seeking a skilled Senior Project Manager to join our VELUX Group's Finance Transformation & Project Management Office (TPMO). This is an exciting opportunity to drive transformation and deliver strategic projects, collaborating with our global team in Denmark and Poland.Your Key ResponsibilitiesLead transformative projects and programs,...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    Exciting Opportunity in Global Data ScienceWe are seeking a highly experienced and visionary leader to spearhead our Clinical Reporting function as Director for Clinical Reporting within our Global Data Science team.About the Role:As a key member of our Clinical Data Science management team, you will be responsible for leading a dedicated team of 7 employees...


  • Hørsholm, Hørsholm Kommune, Denmark Chr. Hansen AS - Novonesis Full time

    Global Category Management Role OverviewWe are seeking a highly skilled Strategic Category Manager to lead our global logistics category management team.About the Role:Oversee the logistics category, driving strategic procurement and innovation to achieve business goals.Develop and implement sustainable global category strategies aligned with business...


  • Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time

    About the RoleAs a Lead Financial Strategist for our Global Allergy Immunotherapy team, you will play a pivotal role in shaping financial strategies and insights that impact our organization.Key ResponsibilitiesDevelop business cases by leveraging your financial expertise to provide analysis and recommendations that support decision-making.Collaborate with...


  • Hørsholm, Hørsholm Kommune, Denmark Chr. Hansen AS - Novonesis Full time

    OverviewChr. Hansen A/S - Novonesis, a leading global biosolutions company, seeks an experienced Global Category Manager to join its growing procurement organization.The ideal candidate will have a proven track record in strategic procurement and category management, with experience in logistics and supplier relationship management.The successful candidate...