Head Quality Management

Head Quality Management

Santhera Pharmaceuticals

Pratteln, Switzerland

Scope of Work

The Head of Quality Management (QM) serves as a key organisational leader, responsible for defining, implementing, and monitoring a risk-based quality management strategy aligned with the company's objectives, regulatory obligations and product lifecycle. This role requires strategic oversight, a focus on operational execution excellence, and the ability to inspire a global, cross-functional quality culture.

The incumbent will act as a champion of quality excellence, ensuring that all processes comply with global laws, regulatory requirements, industry standards, and best practices. This position holds accountability for embedding a proactive, 'right-first time' quality mind-set across all levels of the organization.

Key Responsibilities

Strategic Leadership

• Serve as the primary advisor to senior leadership on quality and compliance matters, contributing to the broader organizational strategy;
• Develop and articulate a forward-thinking, risk-based quality strategy that supports both regulatory compliance and business innovation;
• Provide strategic direction and guidance to the global Quality Management Organization, ensuring alignment with corporate goals.

Operational Excellence

• Drive the design, implementation, and continuous improvement of the company’s Quality Management System (QMS), ensuring it is fit-for-purpose across the product lifecycle;
• Oversee harmonization of quality processes globally, ensuring scalability and efficiency while maintaining compliance with GxP standards;
• Monitor emerging regulations, ensuring proactive adaptation to maintain global compliance;
• Define, oversee and maintain Quality related deliverables within defined timelines and budget.

Team Leadership & Collaboration

• Lead and mentor a team of quality professionals, fostering a high-performance, collaborative environment;
• Build and maintain strong relationships with internal and external stakeholders, ensuring quality initiatives align with business needs and support timely delivery of key projects;
• Promote professional growth within the team, ensuring robust succession planning and skill development.

Risk Management & Audits

• Establish and execute internal and external risk-based audit programs, ensuring readiness for regulatory inspections and audits;
• Lead initiatives to mitigate quality risks, driving a culture of proactive risk management;
• Provide critical input to Risk Management Plans, influencing decision-making at the highest levels.

Regulatory Compliance & Business Processes

• Ensure timely preparation for regulatory inspections, including hosting and follow-up activities;
• Oversee vendor and partner qualification processes and maintain compliance with GxP requirements;
• Manage validation of electronic systems to ensure adherence to global regulatory standards (including GxP document system and Learning Management Systems);
• Provide input into GxP related matters in due diligence for business opportunities.

Communication & Reporting

• Lead and chair the cross functional Santhera Quality Council with company-wide senior leadership;
• Generate and present quality metrics, trends, and status reports to senior leadership, quality status summaries and mitigation plans to Board of Directors;
• Communicate quality-related risks and issues to stakeholders, providing balanced, actionable insights.

Required Qualifications & Experience

• Advanced degree in pharmaceutical sciences or related field (PhD preferred);
• Minimum of 10 years in the pharmaceutical industry, with at least 5 years in a leadership capacity;
• Comprehensive and strong understanding of GxP, industry standards and the drug development lifecycle, with practical experience in either clinical operations, manufacturing, or pharmacovigilance;
• Proven ability to lead and influence remote, cross-functional, and international teams;
• Expertise in designing and executing quality systems and audit program;
• Fluent written and oral English (additional language skill advantageous).

Required Competencies & Skills

• Leadership & Vision: Demonstrated ability to inspire teams and drive organizational change;
• Strategic Thinking: Proficiency in developing long-term quality strategies aligned with business goals;
• Collaboration: Strong interpersonal skills, with the ability to build consensus among diverse stakeholders;
• Communication: Excellent written and oral communication skills, with the ability to convey complex ideas clearly with proficiency in MS Office suite;
• Problem-Solving: A proactive and pragmatic approach to addressing challenges.

For this position, the relevant working/residency permit or Swiss/EU-Citizenship is required.

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