Quality Site Head

Quality Site Head Job Description:

• Manufacturing Quality Assurance work includes:Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product
• Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products
• Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards Reporting and troubleshooting manufacturing process deviations and defects in finished goods
• Quality Site Head Essential Functions:Ensure review and approval of Quality and Manufacturing SOP's, BOM's and Master Documents.
• Coordinate with other members of the management's operating team in the day-to-day conduct of the site's business.
• Ensure approval and monitoring of all Manufacturing suppliers, vendors and contract manufacturers, including company REFS Services as applicable.
• Maintain the laboratories in a validated state and, along with Materials, Manufacturing and MS&T heads, maintain the plant in a validated state.
• Ensure proper approved testing procedures for raw materials, bulk products, finished products, packaging components and critical systems are in place and followed.
• Ensure tracking, evaluation and reporting of key performance indicators (e.g., on time release, etc.,) to determine need for corrective and preventive actions.
• Monitor product performance via customer feedback and internal performance data and assure systems are in place for continuous improvement.
• Monitor fiscal performance, report trends, and take timely corrective actions as required.
• Serve as Management / Deputy Management representative responsibilities as applicable.
• Provide a safe working environment for associates, contractors, and visitors.
• Ensure compliance with Health Safety and Environmental standards at all levels of the organization.
• Ensure associates have tools and equipment needed to perform their jobs safely and effectively Strategy and Direction
• Setting: Develop and implement procedures and methods to ensure that the Quality unit and the Manufacturing unit are in compliance with GMP's, Corporate Standards and other applicable regulatory standards.
• Assist, develop and implement solutions to improve quality, demonstrate ongoing control and increase cost efficiency.
• Ensure optimal alignment with other site functions in terms of targets and metrics and direct QA/QC teams towards higher performance levels.
• Ensure the organization has appropriate succession and associate development plans.
• Ensure organization is staffed with well qualified, trained, and forward focused individuals to assure continuous improvement and compliance with internal and external regulatory standards.
• Coordinate proactively with other facilities and division functions to assure appropriate levels of involvement, guidance, and direction.
• Ensure compliance with regulations (e.g. 21 CFR 210 /211 and Medical Device Regulation 2017/745) and established standards (ISO/EN ISO 13485:2016)