Quality Assurance Lead
4 days ago
Cosmetica Laboratories Inc. is a leading innovator in the cosmetics industry, recognized for excellence and commercialization with award-winning products. We offer an unparalleled array of services that inspire, create, and deliver every step of the way. At Cosmetica Laboratories, we value talent and want you to help us create beauty in the world.
About the RoleWe are seeking a highly experienced Quality Assurance Lead to oversee and direct our Quality Assurance & Quality Control strategy, Quality Management Systems, and policies and programs. As a key member of our senior management team, you will be responsible for ensuring end-to-end quality governance, developing and implementing our quality system strategy, and translating our quality strategy into SOPs, tactical policies, processes, and procedures to ensure compliance with regulatory standards and customer requirements.
Key Responsibilities- Define, develop, and implement short-term and long-term strategies, goals, and objectives relating to cosmetics and OTC quality system regulatory requirements and quality assurance functions.
- Expand quality capabilities to embed quality governance across our end-to-end processes through an integrated product and process design and development structure.
- Implement robust Quality Planning, Engineering, Control, and Assurance.
- Increase efficiencies through streamlined testing methodologies and processes.
- Improve Quality and reduce COPQ.
- Develop a robust Supplier Management Program to ensure that quality standards are being met throughout the supply chain, and to identify any quality issues or potential risks.
- Implement a continuous improvement program that focuses on identifying and addressing areas for improvement in the quality system, efficiency, and cost-effectiveness.
- Develop and implement a product testing program to ensure that products meet or exceed industry standards and customer expectations through the development and implementation of testing protocols, regular product testing, and analyzing test results to identify areas for improvement.
- Design and develop key quality, compliance, and performance indicators. Implement and enforce best practices, processes, guidelines, systems, and technology to support and enhance the quality assurance function and the quality management system.
- Keep current on changes in industry and regulatory quality standards and advise on business impact.
- Collaborate effectively with cross-functional teams, including R&I, Operations, Engineering, Supply Chain, and other internal functions to act as a strategic partner in improving the quality of products and processes.
- Develop and manage relationships with senior Quality representatives from clients, suppliers, and collaborators, ensuring that quality standards are being met throughout the supply chain.
- Communicate quality-related issues and concerns to senior management, providing recommendations for improvement, and ensuring that quality is a key consideration in organizational decision-making.
- Manage and lead the Quality team, including setting team goals and objectives, assigning roles and responsibilities, performance management, and optimizing the organizational structure to meet business needs.
- Provide technical assistance and direction in the areas of quality engineering, compliance, chemistry, microbiology, and physical testing to ensure adherence to quality standards and objectives.
- Responsible for capability building, staffing, and ensuring training of employees; planning, assigning, and measuring work; development of staff, talent assessments, and succession planning.
- Lead the Quality Assurance department as client projects transition from early phase through product innovation and commercial development/manufacturing to release readiness.
- Ensure consistent quality standards across all relevant key business processes.
- Assess current, and where needed, develop corporate and/or other organizational policies related to compliance and oversee their implementation, including quality standards and SOPs.
- Act as a strategic advisor to ensure all internal and external quality issues are properly investigated and documented, and corrective and preventative measures are recommended and implemented.
- Ensure the company is always ready for inspection; accountable for managing regulatory agencies and customer audits. Manage, as the primary point of contact, internal and regulatory agency inspections.
- Direct the quality control department programs involving inspection/testing, methods, devices, and controls.
- Oversee the planning and conduct internal and external audits to ensure compliance with regulatory requirements and GMP requirements for investigational and commercial manufacturing, and ensure corrective actions are implemented to resolve audit findings.
- Use incident and Corrective and Preventive Action (''CAPA') activities and processes to drive quality improvements and respond to process and service issues.
- Provide quality-related guidance and support to other departments, such as R&I, production, engineering, and maintenance, and supply chain, to ensure that quality standards are upheld throughout the organization.
- Monitor and analyze quality metrics to identify areas for improvement and develop and implement strategies to address any issues.
- Develop, implement, and monitor Quality operation budget to ensure compliance with approved expense limitations. Determine cause of variance to budget and applicable corrective actions.
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