Regulatory & Quality Project Lead

About the role

This role supports quality assurance and commercialization for nicotine products, ensuring compliance with regulatory requirements and quality standards from development through launch. The ideal candidate has experience in quality management, product commercialization, and regulatory compliance within a regulated industry. The role also serves as a subject matter expert (SME) for new product launches at Altria or third-party sites, supporting regulatory preparedness, risk assessments, site audits, change control, process qualification, and training.

Responsibilities

• Evaluate and define project-appropriate quality strategies for innovative product manufacturing and implement according to project timelines.
• Collaborate with cross-functional partners such as contract manufacturers, Product Development, Marketing, Packaging Services, Purchasing, Finance, Legal, and Regulatory Affairs to assure compliance with product quality and regulatory requirements.
• Establish project-specific Quality Management System (QMS) for innovative product manufacturing in compliance with Altria Quality Requirements (control plans, SOPs, records, etc).
• Provide evaluation, input, requirements, and training for development and implementation of QMS documentation, records, and quality standards/controls.
• Support quality activities for innovative product manufacturing: change controls, investigations, CAPAs, risk assessments, evaluating change controls for product impact (e.g., specifications, QMS system, regulatory, product supply, implementation timing, impact to qualified/validated state).
• Support the generation of innovative product manufacturing submissions documentation for regulatory reporting.
• Provide support for internal audits and FDA inspections (PMTA pre-approval).
• Communicate regarding projects/activities to ensure alignment on expectations, timing, and next steps.

Requirements

• Bachelor’s degree
• 4+ years’ experience working in quality or regulatory in an FDA regulated industry.
• Knowledge and understanding of various legal, regulatory, and quality assurance principles required.
• Ability to handle multiple responsibilities, priorities and tasks, and work across multiple operations/functions to execute quality initiatives.
• Experience utilizing project management software (Microsoft Project, Smartsheet, etc.)
• Strong working knowledge of Quality Management Systems and critical processes in manufacturing regulated products.
• Must be resourceful in detecting trends, problems, and opportunities for improvements as well as assisting in decision-making and developing recommendations.

Pay

The Salary Range for this position is: $104,900.00 - $152,150.00.

Benefits

• Flexible and remote work options
• 15 days of paid time off, 13 paid holidays, 2 floating holiday days, and a 37.5-hour workweek
• Annual merit increases and performance bonus
• 401(k) matching from day one, plus Deferred Profit Sharing (13%-17% of base salary)
• Student loan repayment assistance and professional development stipends
• Comprehensive medical, dental, and vision coverage for you and your family
• Paid parental and bonding leave
• Wellness programs for whole well-being
• Paid volunteer days