Clinical Quality Assurance Director

1 day ago


Stockholm, Stockholm, Sweden Sobi, Inc Full time

About Sobi, Inc.

Clinical Quality Assurance Manager

At Sobi, Inc., we are committed to delivering high-quality Investigational Medicinal Products (IMPs) that meet the highest standards of quality and compliance. As a Clinical Quality Assurance Manager, you will play a pivotal role in ensuring the quality and compliance of our IMPs through your leadership and guidance of supplier management teams.

Key Responsibilities

  • Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
  • Maintain oversight of quality topics for Sobi IMPs across markets.
  • Continuously improve work processes related to quality and compliance of IMPs.
  • Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials.
  • Monitor and manage key performance indicators (KPIs) related to IMP supplier quality.
  • Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
  • Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues.

Required Skills and Qualifications

  • Bachelor's degree or equivalent education/degree in life sciences.
  • Solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
  • Minimum (10) years of experience within pharmaceutical, biotech product.
  • Relevant experience from working with quality aspects of medicinal products in clinical trials, especially batch allocation and supply to clinical trials.
  • Extensive experience in QA operation, production or other relevant area (GMP, GDP).
  • Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferably other regions such as APAC and LATAM.
  • Strong understanding of risk assessment and risk management fundamentals/tools.
  • Fluently spoken and written English.

Benefits

  • Emphasis on work/life balance.
  • Collaborative and team-oriented environment.
  • Opportunities for professional growth.
  • Diversity and Inclusion.
  • Competitive compensation for your work.
  • Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments.


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