Head of QC Network 100% (m/f/d)

The Head QC Network will develop a strategy for managing lab operations and ensuring global compliance. This role leads a broad network worldwide to improve lab processes and implement strategic programs like LEAN Lab; Smart/DigiLab and GreenLab. This role also includes overseeing QC end-to-end release processes, ensuring comprehensive quality control, and developing a road map for strategic efficiency and operational excellence projects. Additionally, this role will focus on transformation through the integration of digital solutions and new technology, while maintaining regulatory intelligence and readiness.

Key Responsibilities

1. Strategic Leadership:
   • Own and develop strategies for managing network's laboratory operations, ensuring compliance with global standards and guidelines.
   • Lead a team and network focused on enhancing laboratory processes and implementing innovative programs such as LEANLab and Smart/DigiLab.
   • Oversee QC release processes and ensure end-to-end quality control across all operations.
   • Drive the implementation of the GreenLab initiative to promote sustainability and environmental responsibility.
2. Operational Excellence and Continuous Improvement:
   • Implement laboratory quality management systems to meet legal requirements, ensure process and service quality, and maintain a safe workplace.
   • Adhere to standards and processes.
   • Identify and mitigate risks affecting ArCera legacies.
   • Improve efficiency with LEAN Lab and Smart/Digilab programs.
   • Develop QC standards and translate them into procedures.
     • Establish KPIs for QC performance across sites and third parties.
     • Keep management informed about critical issues that might impact lab performance, product quality, compliance, or safety.
     • Ensure continuous improvement through end-to-end quality control.
   • Promote sustainability with the GreenLab initiative.
     • Provide ongoing training to keep the QC network updated on industry standards and technologies.
   • Provide expertise and recommendation for investment strategy in analytical techniques.
   • Foster a learning and continuous improvement culture through ongoing guidance and coaching to the QC network community.
3. Crisis and Risk Leadership:
   • Point of escalation and subject matter expert for critical OOS laboratory investigations.
   • Assess QC process risks, identify and measure the effectiveness of mitigating controls.
   • Assess third party QC service providers through due diligence assessment or formal audit processes.
   • Manage and resolve customer complaints related to product quality, ensuring timely and effective resolution.
   • Ensure adherence to SOPs, Quality Directives, and other related documentation during all stages of product development and manufacturing. Implement robust self-inspections and collaborate with the internal audit department to maintain high standards of product quality and compliance.
4. Talent & Team Development:
   • Lead and develop a high-performing QC network team , fostering collaboration across functions, manufacturing sites and commercial regions. Focus on upgrading capabilities and building a future-ready organization.
   • Develop talents and foster a growth-mindset, promoting a culture of business acumen and continuous learning.
   • Establish Quality & Data integrity culture and awareness, ensuring that all team members understand and prioritize these principles.
   • Establish capability-building and upskilling programs to enhance current quality departments, preparing them for future challenges and opportunities.
5. Organizational Savviness:
   • Collaborate with other departments to identify and address quality issues.
   • Oversee quality assurance activities related to the entire product lifecycle management, ensuring each phase meets the highest standards.
   • Navigate and influence a complex matrix organization, balancing global standardization with local flexibility.

Key Competencies

• Strategic thinking and planning;
• Leadership and team management;
• Regulatory compliance and quality assurance;
• Continuous improvement and process optimization;
• Effective communication and collaboration;
• Analytical and problem-solving;
• Risk management and preventive compliance;
• Data analytics and trend analysis;
• Digital tools proficiency;
• Strong Business acumen.

Qualifications & Experience

• 10+ years of management or team leadership experience in a QC / R&D analytical laboratory environment;
• Operational experience in quality control and analytical chemistry including microbiology;
• Degree in life sciences with a strong focus on analytical chemistry and or microbiology;
• Technical QC expertise and understanding of site QC operational environment;
• Knowledge of ISO 17025 and ISO 9001;
• Strong leadership, communication and project management skills; able to work and influence independently and through a network of specialists;
• Demonstrated knowledge and understanding of the regulatory environment and requirements;
• Experience with LIMS technology and laboratory IT systems; SAP knowledge an advantage, Digital Savvy;
• Experience in change management to drive continuous improvement and quality culture agenda in QC.