Global Quality Management Director

5 days ago

Stockholm, Stockholm, Sweden Sobi Full time
Job Description

Job Summary:

The VP Head of Global Quality Assurance will lead and manage Sobi's Global Quality department, responsible for ensuring compliance with regulatory requirements worldwide. This role requires a strong leader with experience in quality management, regulatory affairs, and pharmaceutical manufacturing.

Key Responsibilities:
  • Quality Compliance: Ensure products, processes, and systems are in compliance with regulatory requirements and Sobi's global procedures.
  • Quality Management System: Lead the design, implementation, and development of a proactive and efficient Quality Management System.
  • Vendor Management: Establish and maintain a proactive and efficient Quality oversight of all relevant vendors and suppliers.
  • Regulatory Compliance: Ensure efficient operations, collaboration, and interconnectivity within the quality area for all vendors and suppliers.
  • Audit and Inspection: Accountable for Sobi's GxP compliance audit plan and execution, regulatory inspections, and inspection readiness.
  • Product Release: Responsible for QP release of products within the area of responsibility.
  • Quality Representation: Ensure Quality and GxP Compliance representation in due diligence and integration activities.
  • Talent Management: Responsible for attracting and retaining talent and the development of all employees in the Quality team.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams to drive quality initiatives and resolve quality-related issues.
  • SHE: Responsible for SHE in own area.
  • Budget Management: Ensure budget adherence and maintain resource overview and plans.
Qualifications:
  • Education: Master degree in pharmacy or other relevant degree (Engineering, Chemistry or alike).
  • Experience: Minimum 20 years' experience from pharmaceutical industry within quality, manufacturing, product development, and/or regulatory affairs.
  • Leadership Experience: Minimum 10 years leadership experience with the ability to inspire and motivate a diverse team.
  • Global Experience: Solid experience of leading a global, multi-cultural organization spread over several continents.
  • Regulatory Knowledge: In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) and quality standards (e.g., GMP, GCP, GDP, ISO) for pharmaceuticals and devices.
  • Vendor Management: Extensive experience of working with quality oversight and operations in an outsourced environment.
  • Manufacturing Experience: Solid and hands-on experience of GMP manufacturing, process, and analytical development throughout the full supply chain.
  • Financial Understanding: Financial understanding and budget management experience.
  • Stakeholder Management: Experienced in working with high-impact stakeholders, e.g., authorities, strategic business partners.
Personal Attributes:
  • Leadership: Strong in leadership and communication.
  • Proactive Mindset: Proactive mindset and actions.
  • Interpersonal Skills: Strong interpersonal and collaboration skills.
  • Result-Oriented: Result-oriented.
  • Problem-Solving: Able to solve complex situations and problems.
  • Conflict Resolution: Able to handle conflicts and create win-win situations.
  • Cultural Awareness: Culture awareness and understanding the way of behavior in different cultures.

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