Career Opportunity

Quality Assurance Systems Manager – EU

Life Molecular Imaging GmbH (LMI) is a German based Research & Development (R&D) organization and a wholly owned subsidiary of Alliance Medical Group Limited. Our vision is to build our position as an innovator and leading player in the Molecular Imaging field. We aim to create value for patients & physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.

For our approved PET tracer NeuraCeq® and our pipeline of tracers in clinical development we offer the following full-time position, to be located in our headquarter in Berlin, Germany or in Europe:

Quality Assurance Systems Manager - EU

Key Tasks and Responsibilities:

  • Maintain & further develop LMI’s electronic Quality Management System (eQMS) re-validation, periodic review, user management and configuration change management
  • Assume role of SOP officer:
    • Organization, maintenance and further development of LMI SOPs and quality documents
  • Personnel training management:
    • Maintain training matrix, job descriptions and resumes of LMI employees
    • Manage personnel SOP training including effectiveness checks
    • Manage onboarding training, as well as offboarding of leaving employees
    • Maintain electronic personnel training system (e-learning tool)
  • Overseeing Change Control-, internal deviation- and CAPA-systems
  • Preparation, attendance and follow-up of compliance inspections by authorities and audits by vendors, including implementation of actions related to area of responsibility
  • Support compilation of data for the yearly QA management review/ status report
  • Support with application for and maintenance of Wholesale Distribution Authorization – WDA(H)

Skills/ Education:

  • University degree or comparable education in a science field (chemistry, biology, pharmacy or equivalent)
  • Several years’ job experience in Quality Assurance in a pharmaceutical national or international environment
  • Experience with and interested in electronic Quality Management Systems
  • Experience in EU-GMPs in specific Chapters 1, 2 & 4, Annex 11, preferably familiar with EU GDPs
  • Attention to detail and quality orientation
  • Strong organizational skills with focus on routine work
  • Excellent computer skills, in particular in Word and Excel
  • Fluency in English

If you want to become part of an entrepreneurial team, if you are prepared to assume a wide range of responsibilities and if your background and personal experience fits this profile, please send us your complete application (Cover letter detailing your interest in this position and CV) as a single pdf document to:

Annekathrin Kirchner   jobs@life-mi.com

We are looking forward to receiving your application!

* The person counts, not the gender!
Life Molecular Imaging is committed to diversity, rejects discrimination and does not think in categories such as gender, ethnic origin, religion, disability, age or sexual identity.

Life Molecular Imaging GmbH is an Equal Opportunity Employer. We believe what we do and our culture of “More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment.

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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