Share Email Opening Title Quality Director  Description Job Responsibilities - Director QA/QC Assure compliance with all current Good Manufacturing Practices (cGMP) 21 CFR Part 111 & Part 211, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) regulations, as well as all applicable company compliance guidelines, standards, and objectives. Assures quality products and processes by establishing and enforcing quality standards and testing materials and products. Assist and manage inspections by FDA, other regulatory agencies and company's commercial partners. Coordinate with regulatory agencies and other external auditors to build trust and confidence in the site's quality systems. Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures. Provide technical and administrative leadership to the QC & QA Staff. Assist in quality input on contracts and serve as the contact for quality agreement negotiation with CMOs & material suppliers. Ensure that quality activities in support of company initiatives are adequately staffed and that timelines are met in a quality manner; establish and manage quality metrics, including Right First Time, responsible for ensuring that all policies and procedures associated with the department are created, current and followed. Ensure training and preparedness of the company at all levels for cGMP compliance. Provides leadership and is accountable for the review and disposition of all products manufactured or packaged for the company by CMOs, including but not limited to the review and approval of all batch records, deviations, and investigations. Provides oversight to customer complaint and Pharmacovigilance services to assure compliance with all applicable regulations. Serve as the quality resource/expert for process development, technology transfer, equipment and facility engineering, validation and troubleshooting. Assist in directing the external audit programs to ensure that the cGMP/GMP requirements are being achieved for all API, excipient, packaging suppliers, CMOs, Contract Service Providers, including contract laboratories. Develop, manage, monitor, and adherence to the overall Quality Control and Quality Assurance budget. Collaborate closely with the Commercial, Research and Development (R&D), and Marketing teams for New Product Launches. Support and participate in the Company's due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.   Position Requirements   Full-Time/Part-Time Full-Time   Aspire Website www.aspire-pharma.com   Position Quality Director   Number of Openings 1   Number Filled 1   Exempt/Non-Exempt Exempt   Hiring Manager(s)   Location Aspire Pharmaceuticals Inc.   About the Organization Aspire Pharmaceuticals is a global leader in soft gelatin manufacturing. Our stringent procurement operations backed with rigorous analytics and testing infrastructure provides custom solutions for our clients from concept to delivery. We are here to guide our clients to innovate better all while optimizing their product journey. As industry trailblazers we are constantly looking to think beyond the status quo. As a leader in the development and manufacturing of soft gelatin nutritional supplements, we take that role with pride. Our singular vision starts with a question. How can we do it better? This sense of wonder is our driving force to create the highest quality products in the industry. No matter how the process starts, we always go through extensive testing studies, and refinement resulting in a superior encapsulated product. Innovate. Formulate. Encapsulate. As our mantra suggests we are focused on innovation. We strive to revolutionize soft gel manufacturing and are determined to always be improving our own capabilities- from enhancing our cGMP lab to employing the use of robotics and vision camera inspection on the production floor. As a center of excellence for encapsulation we know how to consistently optimize the process all while providing our clients with the best possible products.   This position is currently not accepting applications. To search for an open position, please go to http://AspirePharmaceuticalsInc.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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