Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

The Senior Quality Assurance Specialist will provide quality assurance support within a pharmaceutical manufacturing environment, with a focus on manufacturing quality, quality systems, aseptic processes, and combination products. This role will lead and coordinate quality projects, support process improvements, analyze quality performance metrics, and help ensure product, process, and system activities comply with applicable corporate and regulatory requirements.

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.
• Support deployment of global pharmaceutical quality initiatives in partnership with centralized functions.
• Analyze, manage, and maintain cycle-time, touch-time, task, and process data to optimize Quality Assurance performance.
• Drive development, improvement, and maintenance of site Quality Assurance planning and scheduling activities.
• Implement and maintain visual management tools to monitor key quality processes.
• Analyze and report metrics for planned and unplanned quality activities.
• Identify project and quality risks early and establish appropriate mitigation and fallback strategies.
• Lead development of project charters, establish project objectives, and document stakeholder requirements.
• Support regulatory inspections associated with new market introductions.
• Lead and 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 within Manufacturing Quality or pharmaceutical Quality Assurance.
• Experience with Aseptic Processing in a regulated manufacturing environment.
• Working knowledge of Quality Systems and pharmaceutical quality processes.
• Experience coordinating or managing cross-functional Quality Projects.
• Strong Project Management skills with the ability to drive deliverables across multiple stakeholders.
• Strong communication and cross-functional collaboration skills.
• Ability to analyze quality metrics, process data, cycle times, and operational performance.
• Experience identifying project risks and developing appropriate mitigation strategies.
• Familiarity with regulatory compliance requirements within pharmaceutical manufacturing.

Preferred Qualifications:

• Experience with Combination Products.
• Experience supporting regulatory inspections or new-market introductions.
• Experience working with third-party manufacturing or quality organizations.
• Experience with Quality Assurance planning, scheduling, visual management, or continuous improvement initiatives.
• Ability to support approximately 20% travel.

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