Job Description

The Head of Quality Management System & Digital is responsible for defining the strategy and framework for Quality Management System as well as its execution and oversight in relation to all GxP (Good Practice) relevant activities throughout product lifecycle stages across all ArCera regions and entities. This role ensures that the framework enabling ArCera to meet the highest standards of quality and regulatory compliance, specifically adhering to various GxP guidelines, including Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), and Good Documentation Practice (GDocP) for all products and processes is established and maintained in alignment with evolving regulatory standards.

The Head of Quality Management System & Digital will lead a team of quality professionals and work closely with other departments to ensure regulatory compliance and drive continuous improvement in quality systems and processes. Additionally, this role will oversee development and execution of GxP training programs to facilitate continued proficiency of the staff involved in GxP relevant activities within the Quality Management System framework.

Furthermore, this role will develop and implement strategic initiatives to enhance regulatory intelligence, anticipate industry trends, and engage externally with regulatory bodies and industry stakeholders. This will involve staying ahead of regulatory changes, fostering relationships with external partners, and positioning ArCera as a leader in quality management within the life sciences sector.

This role will also establish a strategy to implement LEAN processes, develop fit-for-purpose procedures, and eliminate process redundancies to ensure that all quality management processes are efficient and effective. This involves streamlining operations, reducing waste, and digitalization and automation of operational activities in alignment with company’s strategic priorities and innovation agenda. By focusing on continuous improvement and operational excellence, this role will help drive ArCera's commitment to quality and regulatory compliance.

Key Responsibilities

1.Strategic Leadership:

• Develop and implement quality management strategy and framework including corporate policies and standards for all ArCera regions and entities, ensuring consistency, regulatory compliance, and operational excellence.
• Collaborate with cross-functional leaders (e.g., Manufacturing, Commercial, Regulatory Affairs, Supply Chain) to integrate business needs into QMS strategies and product lifecycle management.
• Anticipate future trends in healthcare regulations, technology, and customer expectations to position quality as a competitive advantage, fostering innovation and trust in products and processes.

2.Operational Excellence and Continuous Improvement

• Oversee QMS processes and ensure the integrity of all quality management activities.
• Drive continuous improvement initiatives to enhance QMS efficiency and effectiveness.
• Utilize trend analysis and data analytics within the QMS to drive decision-making and continuous improvement.
• Leverage digital tools to enhance execution, reporting and monitoring capabilities.
• Ensure global and local QMS operations are harmonized, agile, and responsive to market needs while remaining inspection ready.

3.Crisis and Risk Leadership:

• Identify and mitigate potential risks related to Quality Management System including regulatory compliance.
• Embed risk management principles into Quality Management System processes to ensure potential risks are properly identified, assessed and mitigated.
• Implement a robust mechanism to oversee implementation of ArCera Quality standards across all regions and entities and collaborate with Audit & Compliance team to ensure high standards of product quality and compliance are maintained.

4.Talent & Team Development:

• Lead and develop a high-performing team, fostering collaboration across functions and 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.
• Role Model ArCera values
• Change Leadership, Lead yourself, Lead business, Lead others

5. Governance and Compliance:

• Ensure compliance with all relevant regulatory requirements and industry standards.
• Represent the company in regulatory inspections, audits and Pharma associations.
• Establish and monitor Key Quality Indicators (KQI) to track performance and identify trends.

6.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.

7.End-to-End Global Network Transformation & Optimization:

• Monitor and report on key quality metrics and performance indicators.
• Drive initiatives to optimize the global QMS network and enhance operational efficiency.
• Enable scalable, future-ready processes, leveraging automation, data analytics, and cross-functional workflows to optimize quality impact.
• 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 thinking and problem-solving
• Risk management and preventive compliance
• Data analytics and trend analysis
• Digital tools proficiency
• Strong Business acumen

Qualifications & Experience

• Strong analytical and problem-solving abilities
• Bachelor's degree in a related field; advanced degree preferred
• Minimum of 10 years of experience in quality assurance or a related field
• Proven experience in a senior leadership role overseeing networks in multiple sites and / or commercial regions, with understanding of local and global regulations
• In-depth knowledge of regulatory requirements and industry standards
• Strong leadership and team management skills
• Excellent communication and interpersonal skills
• Ability to work collaboratively with cross-functional teams

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