Requirements:

• Bachelor's degree in a scientific field, including chemistry or pharmacy; advanced degree preferred
• Knowledge of pharmaceutical quality systems supporting development and manufacturing environments
• Experience with small companies and establishing a culture of quality
• Sound knowledge of international pharmaceutical regulations, especially Good Manufacturing Practices requirements of major Health Authorities (e.g., US FDA, European Health Authorities)
• Minimum 2-5 years of working in a Good Manufacturing Practices environment, ideally in more than one of the following areas: development, analytical laboratory operations, chemical and process development, active pharmaceutical ingredient development or manufacturing operations
• Minimum 2-5 years of working in Quality Assurance (QA) in one or more of the above areas; experience in developing and/or implementing Quality Management Systems preferred
• Working experience with innovative technologies and their development and QA requirements (e.g., Quality by Design, Process Analytical Technologies, continuous manufacturing or related technologies)
• Capable of working independently and as part of a cross-functional team of experts; capable of influencing and creating alignment across multiple functional areas
• Strong leadership presence with ability to effectively interact with and present to senior management, clients, and health authority representatives (e.g., inspectors)
• High agility in adapting to changing environments and regulatory requirements (e.g., ability to apply existing quality principles/concepts to novel technologies and modes of production)
• Strong communication and negotiation skills, good listener
• Mindset of continuous improvement; able to challenge the status quo to achieve the best outcome for the organization