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Quality Assurance Intern

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MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.

 

Position Summary

This is an excellent and rare opportunity for someone looking to join a dynamic and young biotech company that is currently on an exciting journey of commercializing a new treatment across the world for a debilitating rare orphan liver disease, changing the world for the better!

We are looking for an energetic, structured and analytical individual to be a part of our international Quality Assurance team based in Europe for the second part of 2024 by supporting the regionalization of the Quality Management System (QMS) for the European Region.

This is an exciting opportunity for a highly motivated Intern educated in Pharmaceutical Technology, Chemistry Biology or with comparable scientific background to support our International Quality Assurance team focused on delivering compliant product to the patients. The selected candidate will undergo comprehensive training about basic elements of Quality Assurance before driving implementation of the regional processes by assessing the existing processes against the related regulations.

You will lead the assessment of the existing local processes against the local requirements and the European Good Manufacturing Practices (GMP) / Good Distribution Practices (GDP) regulations and the development of harmonized procedure applied to the whole region. You will also be involved in further quality system and operational elements like GxP Training, Quality KPIs / Quality Management Review, Quality Technical Agreement, Change Control and Deviation Management. As the last step of the internship, you will provide recommendations regarding the further steps of the Quality Assurance Strategy for the international region at Mirum. You’ll be expected to roll up your sleeves and make an impact over a short period of time!

We’re looking for someone with excellent communication, organizational and analytical skills who works well both alone and as part of a multicultural team. To be successful, this person will need to be a fast learner, effectively prioritize, be able to educate others and deliver operational recommendations during the internship.

What You’ll Be Responsible For…

  • Harmonization and further development of key Quality processes in the international region, e.g. GxP Training, Recall, Batch Tracking, Packaging and Labelling, KPIs and Quality Management Review.
  • Provide guidance and support to ensure effective Quality Management of the product within the region.
  • You will provide recommendations regarding operational efficiency.
  • You will support other ad-hoc Quality initiatives.
  • Work closely with key functions (e.g Regulatory, Supply Chain) and external partners in a multicultural organization.

Requirements:

  • Highly adaptable to change with the ability to execute on decisions quickly Excellent verbal and written communication in English.
  • You need to be enrolled in a scientific M. Sc. Program or equivalent during the internship.

Please include your cover letter with your application.

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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.