Astragaia Labs

About Us: Astragaia Labs LLP is a leading nutraceutical manufacturing company focused on producing high-quality botanical extracts and dietary supplements for global markets. With a commitment to quality, compliance, and innovation, we aim to meet the most stringent international regulatory standards. We are currently seeking a highly qualified and experienced Head of Quality Assurance (QA) to lead and elevate our QA function. --- Role Overview: The *Head of Quality Assurance* will be responsible for establishing, implementing, and maintaining a robust quality management system (QMS) in alignment with international and local regulatory requirements. The candidate will lead a large cross-functional QA team and oversee compliance, documentation, audit readiness, and continuous improvement initiatives. --- Key Responsibilities: * Lead the Quality Assurance department to ensure adherence to international quality and regulatory standards for nutraceutical manufacturing. * Ensure full compliance with US FDA regulations including 21 CFR Part 111 (Dietary Supplements) and 21 CFR Part 117 (Food Safety Modernization Act). * Maintain and continuously improve the QMS in accordance with EFSA (European Food Safety Authority) regulations and relevant Indian regulatory requirements (FSSAI, AYUSH, etc.). * Prepare for and lead international regulatory and client audits including US FDA, EFSA, and third-party customer inspections. * Implement best practices in documentation, change control, CAPA, deviation management, and product release processes. * Liaise with cross-functional teams including manufacturing, R\&D, and supply chain to ensure quality integration across the product lifecycle. * Mentor and manage a team of QA professionals including training, goal-setting, and performance evaluation. * Provide strategic leadership in risk assessment, root cause analysis, and regulatory intelligence. * Represent QA in executive-level meetings and communicate key quality metrics to senior leadership. --- Qualifications & Requirements: * Bachelor’s degree in Engineering, Pharmaceutical Sciences, Food Technology, or a related discipline from a leading institution. * MBA from a reputed institution is preferred. * 10 to 15 years of total professional experience, with a minimum of 5 years in a senior QA leadership role in the nutraceutical, pharmaceutical, or food manufacturing sector. * In-depth knowledge and hands-on experience with US FDA regulations (21 CFR 111, 21 CFR 117), EFSA guidelines, and Indian regulatory frameworks (FSSAI, AYUSH). * Proven track record of successfully leading international regulatory audits including US FDA. * Demonstrated ability to lead, mentor, and manage large cross-functional QA teams. * Strong problem-solving, project management, and decision-making capabilities. * Excellent communication, documentation, and stakeholder management skills. --- Why Join Us? * Be part of a mission-driven organization committed to product excellence and consumer health. * Lead a critical function with direct impact on global compliance and product integrity. * Competitive compensation, leadership opportunity, and professional growth prospects.