Director Of Quality Assurance

Company: X4 Life Sciences
Location: Providence
Posted on: February 22, 2021

Job Description:

An award winning Contract Development and Manufacturing Organization are looking for a Senior Manager or Director of Quality Assurance to join their team in Cumberland, Rhode Island.Director of Quality Position Summary:The Senior Manager or Director of Quality Assurance will oversee and lead project teams to deliver business results focused on improving production processes to improve reliability, increase simplicity and enable growth. The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients and peers.Senior Manager or Director of Quality Assurance will meet manufacturing and company goals in staff development, safety, product quality, production efficiency, and leadership. This position will ensure the operation of the facility and the equipment are in compliance with standards, promulgated under Sections 503A and 503B of the US Food, Drug & Cosmetic Act, OSHA, environmental, labor, and other governmental laws and regulations, while following appropriate documentation and quality systems.Director of Quality Responsibilities:* Implement and ensure compliance with US Food, Drug & Cosmetic Act, Section 503A and 503B, 21 CFR parts 210 and 211 and all its related elements such as facilities, documentation (SOPs and validation protocols, etc.), training, reports and records.* Oversee and lead quality systems activities such as metrics, safety, logbooks and documentation management, safety programs, risk assessment management, etc.* Implementation and ongoing support of U.S. FDA compliant manufacturing of aseptic drug products.* Assist with the technical requirements of supply agreements and other external contracts* Serve as an expert in multiple areas and provide information and training to other employeesRequired Education and Experience:* Bachelor's degree in Science or Engineering or related field or equivalent work experience required 7-10+ years of progressive experience within a cGMP and or a 503B outsourcing facility.* A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices.* Knowledge and understanding of US and International regulatory guidelines and regulations.* Familiarity with manufacturing processes and operations, automation, equipment/facilities validation.

Keywords: X4 Life Sciences, Providence , Director Of Quality Assurance, Executive , Providence, Rhode Island