Director of Pharmaceutical Quality Assurance

4 hours ago


Stockholm, Stockholm, Sweden Sobi, Inc Full time

Role Summary:

We are seeking a highly skilled leader to fill the position of Director of Pharmaceutical Quality Assurance. As an experienced expert in analytical science and technology, you will be responsible for overseeing a team of talented scientists, driving analytical excellence across various activities related to commercial product supply.

The successful candidate will collaborate with cross-functional teams to support life cycle management of products and commercial manufacturing, ensuring robust and reliable analytical solutions. This role is based at our Global Headquarters in Stockholm, Sweden and reports directly to the Head of AS&T.

Key Responsibilities:

  • Lead and mentor a team of Analytical Subject Matter Experts for both biologics and small molecule drug products, fostering innovation and technical excellence.
  • Support the continuous supply of Sobi products for patients through collaboration with other parts of Technical Operations as well as Regulatory.
  • Support geographical expansion of Sobi products with launches on new markets and corresponding regulatory submissions.
  • Provide resources within budget to Virtual Plant Team and Product teams, and plan for head count increase in case of constraints.
  • Support the team with planning, prioritization, and delivery of tasks as needed, securing a good working environment and work-life balance.
  • Ensure GMP compliance.
  • Establish and adhere to budget for AS&T.
  • Prepare and execute Performance Management, salary reviews, and ensure development plans are in place for all team members.
  • Support implementation of new analytical technologies.

About You:

You are an experienced leader with extensive experience from life science, pharmaceutical industry, and GMP. You have a background within analytical science and technology or a related field. As a leader, you are structured and result-oriented, communicative, with an ability to coach and mentor colleagues to achieve their full potential. You are passionate about problem-solving, continuously seeking ways to improve processes and drive efficiency. You are also a strategic thinker who understands regulatory requirements and can effectively communicate across departments to drive projects forward.



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