Head of Quality & Regulatory Affairs Advanced Therapy Solutions (x|f|m)

at  Sartorius

The Head of Quality & Regulatory Affairs, ATS will be responsible for the Quality and Regulatory Affairs leadership across the ATS business unit; driving high quality standards, regulatory compliance, and responsible EHS policies, for clear market differentiation and highest customer satisfaction. Responsibility will include pragmatically harmonizing quality management systems across the ATS quality network, creating value-adding synergies within the ATS and broader BPS Quality and Operations organisation, as well acting as the global spokesperson on quality and regulatory matters with customers and authorities. He/she will be a member of the ATS global leadership team and will interact closely with the Head of Operations, ATS as well as the Head of Quality Management for the BPS division, to ensure achievement of quality and operational priorities in alignment with business unit and divisional business objectives.

QUALIFICATION & SKILLS:

• Master’s degree in a relevant life-science or engineering field
• A minimum of ten years industry experience and proven experience as Head of Quality or similar leadership role from the pharmaceutical industry
• In-depth knowledge of international quality standards (ISO and cGMP) and regulatory requirements
• Deep familiarity with all quality functions including quality control, quality assurances, validation, regulatory affairs, and EHS
• Outstanding communication and negotiation skills
• Excellent organizational and leadership skills in a global organization
• Analytical mind with high personal initiative and strong ability to motivate self and others
• Fluent in English
  What we offer

As a growing global life science company, stock listed on the DAX and TecDAX, Sartorius offers a wide range of benefits:

• Personal and Professional Development: Mentoring, leadership programs, Talent Talks, LinkedIn Learning, internal seminar offerings , coaching for managers
• Work life balance: Remote options, flextime, flexible work schedules, sabbaticals

• Provide strategic direction for the pragmatic harmonization of quality management systems, including electronic systems, across the global ATS network of empowered sites to ensure consistent high standards.
• Manage and develop local quality leadership, ensuring adherence to industry standards, regulatory requirements, and company policies.
• Provide guidance to local quality teams and manage projects related on global initiatives to meet business unit and divisional level quality objectives.
• Stay abreast of international regulatory requirements and ensure compliance.
• Develop and maintain relationships with regulatory agencies, ensuring timely submissions and approvals for products/services.
• Work closely with sales and marketing to translate quality expertise and regulatory support to establish differentiated leadership proposition in the market and ensure highest customer service level.
• Monitor and assess internal and external quality standards, leading continuous improvement initiatives in alignment with BPS Quality.
• Develop and implement strategy for regional and global collaboration across the ATS quality and regulatory organisation for value-adding contributions to the overall customer experience as well as the productivity and scalability of the ATS.
• Implement and monitor EHS programs to create and maintain a safe working environment across the ATS and together with legal ensure compliant operations and supply in all territories.
• Supported by the global ATS leadership, manage the development, maintenance, and adherence to global and local business continuity plans for transparent, risk mitigated business operations.