Senior Quality Assurance Specialist

Job Summary:The Senior Quality Assurance Specialist will provide quality assurance support within a pharmaceutical manufacturing environment. The position will support quality activities across products, processes, and systems to help ensure compliance with corporate and governmental regulations, with particular emphasis on Manufacturing Quality, Aseptic Processing, Quality Systems, and Quality Projects. Key Responsibilities:• Develop plans, coordinate activities, and drive execution of quality projects across multiple site Quality Assurance areas.• Coordinate with site Quality Assurance planners to achieve project deliverables.• Coordinate with centralized functions on the deployment of global pharmaceutical initiatives.• Analyze, manage, and maintain cycle-time, touch-time, task, and process data to optimize Quality Assurance process performance.• Support the development, improvement, and maintenance of site Quality Assurance planning and scheduling activities.• Implement and maintain visual management tools to monitor key Quality Assurance processes.• Analyze and report metrics for planned and unplanned quality activities and identify potential areas of risk.• Develop risk assessments and implement appropriate fallback and mitigation strategies.• Lead development of project charters, document stakeholder requirements, and establish project objectives and evaluation criteria.• Support regulatory inspections associated with new market introductions.• Lead or coordinate compliance and performance improvement projects and provide project status updates to site management.• Maintain effective working relationships with Quality Assurance teams supporting third-party contractors. Required Qualifications:• Experience in Manufacturing Quality within a regulated environment.• Experience with Aseptic Processing.• Strong knowledge of Quality Systems.• Experience with Project Management and coordinating quality-related projects.• Strong communication and stakeholder coordination skills.• Ability to analyze quality process data, metrics, cycle times, and operational performance.• Ability to identify quality and project risks and support appropriate mitigation strategies.• Experience supporting quality and compliance activities in a pharmaceutical manufacturing environment. Preferred Qualifications:• Experience with Combination Products.• Experience supporting regulatory inspections.• Experience with compliance and performance improvement initiatives.• Experience working with third-party contractor Quality Assurance teams.• Experience with Quality Assurance planning, scheduling, and visual management processes.• Ability to travel approximately 20%. Benefits:The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable. Pay Range: $30/hr to $40/hr