Overview

Have 10 years of leadership experience in Consumer Package Goods quality systems and operations within an International or an FDA-regulated environment? Have a passion for driving excellence and compliance in everything you do? If so, we want to speak with you!

We are currently seeking a Manager, Regulatory Quality Compliance to join our team in Richmond, VA. or we are open to remote work arrangements.

This role will work with multiple business partners to prepare for FDA Tobacco Product Manufacturing Processes (TPMP) Readiness and Supplier Quality Requirements development. You will collaborate with quality, manufacturing, and Service Organization personnel to evaluate their quality management systems and production processes.

In this role, you will:
• Lead the development of Quality Agreements between Altria and its Suppliers and/or Contract Manufacturing Organizations with a focus on Quality Management System requirements to meet FDA and international regulatory requirements.
• Lead QMS governance activities to prepare for FDA Product applications, FDA Pre-Approval Inspections, and post-market surveillance.
• Provide TPMP Regulatory Quality Compliance support for Suppliers and Contract Manufacturing Organizations, including, but not limited to, Contract Manufacturing Organizations, Contract Laboratory, QMS infrastructure, Risk Assessments, etc.
• Work with import/export services to comply with FDA and regulatory requirements.
• Lead or participate in continuous improvement programs/projects designated to improve the quality and compliance posture of the organization.
• Provide mentorship and recommendations to management on Tobacco Product Manufacturing Practices (TPMP) implementation and issues resolution.
• Participate in FDA Inspection Readiness Plans to support TPMP readiness activities and FDA Inspections. Develop proficiency in industry proposed TPMPs. Generate and lead project plans to address remediation plans. Generate metrics to track project progress.
• Develop, lead, and write position papers that define the rationale for TPMP response and interpretation.
• Generate TPMP gap assessments of existing processes and systems against Altria Quality Requirements (AQR) using multi-discipline, multi-functional teams with a focus on Supplier and Contract Manufacturing Organization Management to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS), and general quality practices.
• Conduct trend analysis and formulate management communications for emerging quality risks related to TPMPs.
• Craft and improve quality requirements and standards through independent research and interpretation of other FDA-regulated industries and standards.
• Participate and/or lead QMS audits and assessments.
• Advance internal and external situations which may pose quality/compliance risks that may adversely affect business operations.
• Conduct analyses, consulting, and assessments of various operations and processes by applying their knowledge and judgment in areas where they may have little to no previous work experience.
• Maintain confidentiality of information acquired during audits and projects.

We want you to have:
• Bachelor's degree in Physical Science, Engineering, or a related field.
• Minimum of 10 years of leadership experience in Consumer Package Goods quality systems and operations within an International or an FDA-regulated environment. Experience with product development preferred.
• Subject Matter Expertise in Supplier and/or Contract Manufacturing Organization Management, including the establishment of Quality Requirements
• Experience interpreting, understanding, and implementing Quality Management Systems, especially International Quality.
• Knowledge of Import/Export Quality Requirements.
• Strong project management skills.
• Strong analytical and organizational skills.
• Working knowledge of Data Integrity and product development-related requirements.
• Strong written, verbal, and presentation skills along with a proven ability to collaborate with others with a focus on multicultural communication.
• Ability to provide critical feedback considerately, independently, and persuasively to the most senior levels of management.
• Proficiency in conflict negotiation and resolution is preferred.
• Perform assignments in an independent and autonomous manner with minimal direct supervision.
• Able to utilize various computer software including Word, Excel, Microsoft Teams, PowerPoint, and Outlook.
• Comfortable working during non-core hours, as required, to assess multiple shifts and operations spanning lengthy periods.
• Business-related travel is expected to be 10-30% with this position and may include domestic and international travel.

At Altria Client Services, we recognize that our people are the reason we achieve our business goals. We believe in developing the leadership potential of our employees by providing them with opportunities for training, development, and advancement.

In addition to the opportunity to apply and develop your skills toward key business objectives, we offer an excellent compensation package including a competitive base salary, comprehensive health/vision/dental insurance, participation in our incentive compensation and deferred profit-sharing programs as well as a relocation assistance package.

Company Overview
Altria has a leading portfolio of tobacco products for U.S. tobacco consumers age 21 . Altria’s Vision through 2030 is to responsibly lead the transition of adult smokers to a non-combustible future. Altria is Moving Beyond Smoking™, leading the way in moving adult smokers away from cigarettes by taking action to transition millions to potentially less harmful choices - believing it is a substantial opportunity for adult tobacco consumers, Altria’s businesses and society. Altria’s wholly owned subsidiaries include the most profitable tobacco companies in their categories: Philip Morris USA Inc. (PM USA), U.S. Smokeless Tobacco Company LLC (USSTC), and John Middleton Co. (Middleton). Altria’s smoke-free portfolio includes Helix Innovations LLC (Helix), the maker of on! oral nicotine pouches, exclusive U.S. commercialization rights to the IQOS Tobacco Heating System®* and Marlboro HeatSticks®*, and an equity investment in JUUL Labs, Inc. (JUUL). Altria also owns equity investments in Anheuser-Busch InBev SA/NV (ABI), the world’s largest brewer, and Cronos Group Inc. (Cronos), a leading Canadian cannabinoid company. At Altria, we celebrate the power of diverse teams working together to shape our future. We are inspired to bring our best because our unique strengths are valued. We believe our personal success and progress should be guided by Our Cultural Aspiration, a new articulation of what we value and who we aspire to be, collectively. Our Cultural Aspiration respects and complements individual identity, embracing each other’s unique strengths, welcoming newcomers and developing the best, most inclusive and diverse teams. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and our shareholders. Each Altria company is an equal opportunity employer. Learn more about Altria at www.altria.com and follow us on Twitter, Facebook and LinkedIn. *IQOS Devices and HeatSticks® are currently unavailable for sale in the United States.