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Quality Assurance Manager - job post

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  • Sjukvårdsförsäkring

Fullständig jobbeskrivning

The ITB-MED Quality Assurance team support across all areas within ITB-MED from pre-clinical, clinical and also manufacturing and distribution of Investigational Products. We are now looking to hire a new Quality Assurance Manager in Sweden.

Job Summary / objective:

The Quality Manager is responsible for deployment and management of Quality Assurance electronic document management system (EDMS), as well supporting in-house training and end users. The role is also supporting the broader team in using the system and managing the documentation within the system. The position reports to the Head of Quality Assurance.

Essential functions:

  • Management of vendors, including maintaining the approved GxP vendor list, oversight of the annual vendor audit plan, tracking audits to closure and filing applicable documentation.
  • Work closely with functional areas and consultants for daily management of workflows and filing documents within the EDMS.
  • Troubleshoot system issues and interface with EDMS vendor technical support as needed.
  • Support activities related to configuration changes and updates for the system, such as support in validation activities during major system maintenance releases.
  • Serve as backup to the Business System Owner for the EDMS.
  • Develop and provide training and in-house support for EDMS users.
  • Create/update documentation/training SOPs, Work Instructions, forms and templates as needed.
  • Provide support during internal audits.

Required education and experience:

  • Bachelor’s BA/BS degree or equivalent experience.
  • A minimum of 2 years of document control/document management experience using EDMS in the pharmaceutical/biotech industry is required; 5+ years preferred.
  • Familiarity with documents and records associated with GxP manufacturing and testing activities and understanding of current regulatory expectations including 21CFR Part 11 requirements.

Preferred education and experience:

  • Experience from working within areas regulated by Good Manfacturing Practise, Good Distribution Practise and/or Good Clinical Practise.

Required Skills/Abilities:

  • Demonstrated ability to work independently, as well as to collaborate and influence across an organization to gain support and commitment for team goals.
  • Strong professional interpersonal and communications skills, both verbal and written, to provide clear direction for the business, vendors, and internal stakeholders.
  • Strong attention to detail, organizational skills, ability to work in a faced paced environment.
  • Ability to meet deadlines and multi-task efficiently.

What we offer:

  • Inspiring facilities & environment working in our new combined lab & office space in “Forskaren”, Stockholm’s new life science centre
  • Competitive pay and benefits such as
    • Excellent healthcare and retirement plans
    • Maximum annual wellness contribution
    • Parental salary supplements
    • Private health insurance and check-ups

We value collaboration, excellence, and openness in our company culture. As a tight-knit team of passionate individuals, we believe in creating an inclusive and supportive work environment that encourages personal and professional development. You will have the opportunity to grow and develop along with the company and be part of groundbreaking innovation in medical research.

Fraudulent Employment Opportunity Disclaimer:

Please be aware that there are certain individuals and entities that fraudulently misrepresent to job seekers that ITB-MED has open employment positions when in fact those positions are not available.

We do not recruit or offer positions via text messages, Signal, Facebook, WhatsApp, or any other messaging platforms.

ITB-MED does not ask you to send money and/or personal details such as banking information, passport and/or visa information. Should you think you have been a victim, please report the incident to legal(at)itb-med.com

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