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Chief Quality Officer

INW Manufacturing, LLC

RemoteUnited StatesexecutiveFull Time
Posted
today
Source
Himalayas

Skills

CommunicationLeadership

Description

Key Responsibilities: - Lead the development, implementation, and maintenance of quality management systems in compliance with all FDA regulations and GMP standards. - Oversee the entire quality control process, including raw material verification, in-process quality checks, and finished product testing. - Oversee laboratory operations. - Manage and enhance the supplier qualification program to ensure raw materials meet required quality and regulatory standards. - Coordinate with R&D and production teams to implement quality standards and improve product consistency and safety. - Lead internal audit programs to identify potential quality issues and implement corrective actions in a timely manner. - Maintain up-to-date knowledge of industry trends, new regulatory requirements, and best practices in quality management. - Train and mentor quality assurance staff and oversee their daily activities and performance. - Manage the handling of customer relations related to product quality, investigating issues and developing solutions to prevent recurrence. - Prepare and present detailed quality reports to senior management and relevant regulatory bodies. - Collaborate with external auditors and regulatory officials during inspections and provide necessary documentation. - Serve as Quality representative to all external organizations. - Establish key metrics and Quality Strategy in line with Company objectives. Required Qualifications: - Minimum Bachelor’s Degree in a scientific field such as Food Science, Chemistry, Biochemistry, Engineering, or related field. - Minimum of 15 years’ experience in quality control or quality assurance in the dietary supplement or pharmaceutical industry, with at least 5 years in a managerial capacity. - Deep understanding of FDA regulations (CFR 21 part 111, 210, 211 and 11), GMP, HACCP, and ISO standards relevant to dietary supplements. - Deep understanding or dietary supplement and pharmaceutical standards – experience in GRMA certification programs. - Proven experience in handling audits and compliance with regulatory bodies. - Strong leadership skills and experience managing a quality assurance team. - Excellent organizational, communication, and interpersonal skills. - Knowledge of modern IT solutions in the space of Quality Management System Preferred qualifications: - Master’s degree in a relevant scientific discipline. - Certifications related to quality management (e.g., Certified Quality Auditor, Certified Quality Manager). - Experience with lean manufacturing and continuous improvement processes. - Experience in managing laboratory operations. - Experience in managing External Manufacturers and vendors. - Prove track record in digitalization and management of transformation. - Experience in implementing QMS. - Experience in automation and in-line process controls. - Proven track record in establishing effective teams. - Experience in creation and implementation of Quality strategy. Skills: - Exceptional analytical and problem-solving skills. - Ability to multitask and manage multiple projects simultaneously under tight deadlines. - Strong attention to detail and a commitment to delivering high-quality products. - Proficient in using quality management software and tools. Originally posted on Himalayas

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