Product Quality Director

5 days ago


Stockholm, Stockholm, Sweden Sobi, Inc Full time
Job Description

The Product Quality Director provides strategic leadership and guidance to ensure the development and delivery of high-quality products that meet regulatory requirements and customer expectations. This role is responsible for ensuring end-to-end compliance for product manufacturing and life cycle management, implementing and maintaining Quality Risk Assessment and KPIs, and leading complex change cases and coordinating product QA activities across markets.

Key Responsibilities:
  1. Compliance and Risk Management: Ensure that all products meet regulatory requirements and industry standards, and identify and mitigate potential quality risks.
  2. Quality Assurance: Develop and implement quality assurance strategies and procedures to ensure the quality of products and processes.
  3. Leadership and Collaboration: Lead cross-functional teams to achieve quality objectives, and collaborate with stakeholders to ensure effective communication and issue resolution.
  4. Process Improvement: Identify opportunities for process improvement and implement changes to enhance quality and efficiency.
  5. Regulatory Affairs: Ensure compliance with regulatory requirements and industry standards, and maintain relationships with regulatory agencies.
Requirements:
  1. Education: Hold a high-level education in pharmaceutical, biotech, or life sciences.
  2. Experience: Possess at least 10 years of experience in pharmaceutical and biotech products, with a strong background in quality assurance and regulatory compliance.
  3. Leadership Skills: Demonstrate strong leadership skills, with a proven track record of managing complex projects and teams.
  4. Communication Skills: Possess excellent communication and interpersonal skills, with the ability to influence and negotiate with stakeholders.
About Sobi, Inc:

Sobi, Inc is a global biopharmaceutical company dedicated to developing and delivering innovative therapies to improve the lives of people with rare diseases. We are committed to making a positive impact on the lives of our patients and customers, and we are seeking a highly skilled and motivated individual to join our team as a Product Quality Director.



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