Scientist Pharmacy, Biochemistry as Quality Assurance Specialist - Pharmacovigilance (m/f/d)

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-nordic.com

To strengthen our Quality Management System and Quality Assurance Department in Martinsried/Munich we are searching for a qualified

Quality Assurance Specialist

Your tasks

  • Perform QA tasks, monitor and evaluate various aspects of Bavarian Nordic regulated studies and activities to ensure standards of quality are met in accordance with FDA, ICH, EMA and applicable regulatory requirements and guidelines pertaining to Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP)
  • Actively contribute to Bavarian Nordic’s quality system in close cooperation within the QA Department as the ell as Clinical Development and Pharmacovigilance team
  • Assist in maintaining and continuously improve the Quality Management System at Bavarian Nordic and increase awareness and knowledge of regulatory requirements in support of clinical research and post-market products
  • Create, review and maintain and track Standard Operating Procedures for compliance with GCP and GVP regulatory requirements, guidelines and industry standards
  • Write, review and/or track Deviation Reports, CAPAs, Change Controls and Investigation applicable to GCP and GVP areas. Participate in root cause analysis, impact assessment, corrective plan, follow up and trending
  • Support audits and regulatory inspections including planning, hosting, report preparation, and release, responses to audit findings, follow up on audit responses and assist in verifying CAPA effectiveness
  • Educate, train staff and coordinate training activities
  • Maintain Clinical QA trackers, folders and documentations up to date and organized to ensure inspection ready

Skills

  • Demonstrated knowledge of FDA, ICH, and EMA GCP and GVP regulatory requirements and guidelines.
  • Must possess a high level of personal integrity, excellent work ethics and respect for colleagues at all levels
  • Ability to work accurately with close attention to details
  • Work proactively and effectively in a fast-paced environment
  • Proven organizational skills and ability to handle multiple diverse projects simultaneously
  • Effective communication and negotiation skills, be able to work with matrix, internal team and external CROs, and be able to break down problems to find solutions

Your Profile

  • BA/BSc Degree in Pharmacy, Biochemistry or any other related course of studies
  • Minimum 2-3 years of work experience in the pharmaceutical or biotech industry, preferably in the area of Quality Assurance
  • Experience managing and tracking Key Quality Indicators and Quality Issues
  • In-dept knowledge of PV compliance would be an asset, especially post marketing
  • In-depth knowledge of Office standard applications (Word, Excel, PowerPoint)
  • Fluent in German and excellent command of English with strong written and oral skills

    Your prospect

    • An exciting position within an international environment
    • Working in a highly motivated team
    • Broaden your experience in an internationally operating, biopharmaceutical company

    Contact

    If you are interested in the position, we look forward to receiving your application in English with your earliest possible start date and your salary expectations (annually) via our internal system.

    Follow the direct link under view details and sign on. You will be redirected to our application form.

    Bavarian Nordic
    Fraunhoferstraße 13
    82152 Martinsried
    www.bavarian-nordic.com

    While applying for the job please refer to jobvector

    About Bavarian Nordic GmbH

    Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases.
    More about Bavarian Nordic GmbH