The Quality Director will oversee all aspects of Quality Assurance, Quality Control, Regulatory, and Compliance functions to ensure that operations align with applicable regulations and standard operating procedures. This role is essential in maintaining product quality, facilitating batch disposition, and meeting regulatory requirements for commercial purposes.
Responsibilities: • Quality Management System: Develop, implement, and maintain an effective Quality Management System that ensures compliance with cGMP, regulatory labeling, specification approvals, testing, and change control requirements. • Product Release: Manage the final release of raw materials, components, and finished products. • Quality Issues: Oversee change controls, deviations, non-conformances, and CAPAs related to quality. Manage product quality issues, including escalation to the Material Review Board (MRB) and Quality Management Reviews. • Inspections and Audits: Oversee inspections and audits from State, Federal, third-party certifiers, and customers, as well as SQF assessments and reassessments. Ensure mock recalls are conducted. • Regulatory and Customer Feedback: Collaborate with internal departments to ensure timely and effective responses to regulatory and customer feedback. • QA Support: Oversee QA on-the-floor support, visual inspection, and batch review and disposition. • Batch Release: Direct raw material testing, batch record reviews, and lot disposition activities to ensure timely release of lots in compliance with SOPs and regulations. • Documentation: Manage the creation, changes, and issuance of QCRs, Batch Cards, and packaging records to production. • Change Control: Manage and train the company on change control processes. • Team Leadership: Foster a collaborative environment and teamwork to achieve organizational goals. Supervise staffing, oversee training and development, and conduct performance reviews. • HR Support: Assist with HR functions, including interviewing, performance reviews, employee relations, and company communication.
Qualifications: • BS degree in Food Science, Chemistry, or related fields (master's degree preferred). • Minimum of 15 years of quality experience in a manufacturing environment, with at least 8 years of managerial experience.
. Must have Nutraceutical manufacturing experience • Proven track record of implementing quality management systems and driving continuous improvement. • Strong knowledge of industry standards and regulations (e.g., SQF, NSF). • Excellent leadership and team management skills. • Ability to work collaboratively with cross-functional teams. • Computer literacy with proficiency in Microsoft Office products. • Strong verbal, written, and communication skills. • Attention to detail, result-orientation, self-motivation, and organization. • Bilingual (English/Spanish) preferred, not required