Senior Manager, Quality Assurance Management

CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

Job Summary:

Working with local leadership and quality teams the role is responsible ensuring effective and consistent definition and execution of the Quality management system. This to be achieved through identification, development and effective application of core competencies required to deliver excellent compliance and quality controls as well as support of compliance and continual improvement within CV owned West Henrietta Packaging and Distribution warehousing operations.

This position functions as a senior leadership member and representative of QARC for designated areas.  Role directly manages exempt and non-exempt staff, including but not limited to quality engineering, document control, internal audit, and, via a subordinate supervisor, additional non-exempt staff performing quality assurance roles in support of operations.  Role will interact with other members of CooperVision’s QARC community, and with external agencies for ISO, MDSAP and other regulatory body audits.

Quality Systems

• Acts as the Management Representative for the Packaging and Distribution facilities
• Develops, implements, and maintains the Quality Management System and quality assurance procedures required to ensure that processes and products comply with applicable quality standards and regulatory requirements.
• Oversees the development of Standard Operating Procedures (SOPs), processes, supporting documents and training materials for quality assurance, global packaging, supply chain, and distribution activities.
• Uses knowledge of Good Manufacturing Practices (GMP), Quality System Regulation (QSR), MDSAP, and other industry standards as well as ISO guidelines in the development of processes and procedures.
• Supports the NCR and CAPA processes, collaborating with process owners to ensure effective root cause analysis and the development of long-term solutions.
• Facilitates continuous improvement, including but not limited to change management activities such as Engineering Change Order (ECO), Packaging Change Order (PCO), New Product Launch Change Order (NPLCO) processes in conjunction with subject matter experts.
• Leads global collaboration efforts to implement the policies and procedures needed to harmonize Quality Systems and processes between sites and functions. 

Operational Support

• Ensures quality standards are met for all products being packaged and distributed from the West Henrietta and that all packaging and labeling materials meet CooperVision / FDA / International quality system requirements. 
• Oversees auditing and / or sampling of processes to ensure conformance with specifications and approves release of products after disposition has been determined. 
• Investigates instances of nonconformance and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions.
• Provides QA support and guidance in areas such as risk assessment, validations, sampling plans, etc.
• Evaluates distribution center and packaging performance capability and develops criteria to monitor and improve existing processes, as measured by appropriate quality KPIs.
• Conducts risk analysis and determines severity of problems and works with the appropriate functions or facilities to solve quality issues. 

Internal / External Audit

• Oversees internal and external Quality Systems audits, acts as site / functional lead in external Quality Systems audits and interfaces with external auditors / regulatory bodies as required.
• Assists in product recalls and other regulatory submissions and responses as needed.
• Provides feedback on product quality in the marketplace.

Management & Staffing

• Responsible for overall management of the QA Department including planning, staffing, training, development, and employee relations to achieve objectives and key performance indicators.
• Involved in determining the strategy for support and expansion of the b