Generate TPMP gap assessments of existing processes and systems against Altria Quality Requirements (AQR) using multi-discipline, multi-functional teams. Plan and conduct research on good manufacturing, good laboratory, good clinical practices, and product development requirements pertinent to FDA regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS) and general quality practices
Lead enterprise FDA Inspection Readiness Plans to support TPMP readiness activities. 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 which define rationale for TPMP response and interpretation
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
Provide mentorship and recommendations to management on tobacco Manufacturing Practices (TPMP) implementation and issues resolution
Lead Quality Compliance activities with respect to TPMP readiness
Participate and/or lead QMS audits
Provide TPMP Quality Compliance support for Vendor and Supplier Management, including, but not limited to, Contract Manufacturing Organizations, Contract Labs, Quality Agreements, QMS infrastructure and risk management
Advise on 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
Lead or participate in corrective actions and programs designated to improve the quality and compliance posture of the organization
Maintain confidentiality of information acquired during audits
We Want You To Have
Bachelor's degree in a Physical Science, Engineering or related field
Minimum of 10 years leadership experience in FDA and or FDA regulated quality systems and operations (pharmaceuticals, medical devices and dietary supplements). Experience in product development preferred.
Working knowledge of Data Integrity and product development related requirements.
Strong analytical and organizational skills
Strong written, verbal and presentation skills along with proven ability to collaborate with others
Ability to considerately, independently and persuasively provide critical and sensitive feedback 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 to include: Word, Excel, PowerPoint and Outlook
Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods
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.
Altria Group is a FORTUNE 200 company that leads the premier tobacco companies in the United States. Headquartered in Richmond, Virginia, Altria Group holds diversified positions across tobacco, alcohol, and cannabis. Our tobacco companies include some of the most enduring names in American business: Philip Morris USA, U.S. Smokeless Tobacco Company, John Middleton, and Nat Sherman. We have 35 percent ownership of JUUL Labs, Inc., the nation’s leading e-vapor company. And we have an 80% interest in Helix Innovations, which manufactures and markets on!, an oral tobacco-derived nicotine pouch product. We complement our total tobacco business with our ownership of Ste. Michelle Wine Estates and our significant equity investment in Anheuser-Busch InBev, the world's largest brewer. Altria’s significant stake in Cronos Group, a leading global cannabinoid company, represents an exciting new global growth opportunity.
At Altria, we recognize that our people are the reason we achieve our business goals. It’s only through diverse perspectives and insights that we will be able to take on the important challenges we will face to dramatically transform our business – and our industry. The work opportunities and experiences, combined with training, development, and advancement programs, allow our employees to achieve their full potential and deliver superior business results. We have the opportunity to make more progress on harm reduction in the next 10 years than we have in the past 50 years. 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.
Altria Group holds diversified positions across tobacco, alcohol and cannabis. Through our wholly-owned subsidiaries and strategic investments in other companies, we seek to provide category-leading choices to adult consumers, while returning maximum value to shareholders through dividends and growth.