Head of QA EU & International

Sobi

Basel or Stockholm

Job Description

You will lead and manage the team QA EU & International reporting to the Head of Global QA External Operations within Global Quality. QA EU & International is accountable for GMP/GDP compliance across Sobi´s external supplier network within EU and International through robust quality oversight including Quality Operations from development to commercial products. QA EU &International is also responsible for ensuring optimal efficacy by embracing operational excellence and fostering a culture of continuous improvement by proactively identify and navigate the opportunities and risks inherent in the lifecycle of Sobi products, maintaining adherence to GMP/GDP standards.

The position is a member of the Global QA External Operations Leadership team.

Lead and manage QA EU & international (RoW excl North America) consisting of QA Supplier managers, ensuring compliance with GMP/GDP regulations;
Responsible for a robust and proactive Quality oversight of suppliers in the regions ensuring adherence to all relevant GMP/GDP regulations and effective agreements;
Ensure products, processes, systems and procedures are in compliance with cGMP/GDP, relevant authority requirements and global Sobi procedures within the area of responsibility including commercial and clinical products;
Implement quality risk assessment and maintain Quality KPIs of suppliers;
Oversee QA release of products and drive efficiency in key quality processes;
Develop and manage functions and people aligned with strategic business goals;
Prepare and maintain budget adherence.

Qualifications

Join our team as the Global Quality Assurance Leader and demonstrate exceptional personal attributes by leading with confidence, driving proactively, solving complex challenges with finesse, fostering cultural awareness, and motivating for excellence. Make a significant impact in the pharmaceutical industry by applying your visionary leadership and passion for quality assurance. Apply now to shape the future of quality assurance with us.

Master's degree/PhD in pharmacy or relevant field;
Minimum 15 years' experience from pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs with leadership experience;
Strong experience in managing external GMP/GDP suppliers;
Strong understanding of regulatory and GMP requirements, external supplier management, and business practices;
Fluent in English;
Experience from working in an international organization and across borders and with different cultures.

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