Manager, Regulatory Quality Compliance.

Overview Have 10 years of leadership experience in quality systems and operations with the FDA or in 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 Regulatory Quality Requirement team. This role will work with multiple business partners to prepare for FDA Tobacco Product Manufacturing Practice (TPMP)’s. 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 or participate in continuous improvement programs/projects designated to improve the quality and compliance posture of the organization. • Develop proficiency in industry-proposed TPMPs and related regulatory rules. Lead enterprise FDA Inspection Readiness Plans to support TPMP readiness activities and FDA Inspections. Generate and lead project/implementation plans to address remediation activities. Generate metrics to track project progress. • Generate TPMP gap assessments of existing processes and systems against Altria Quality Requirements (AQR) by leading multi-discipline, multi-functional teams. Plan and conduct research on good manufacturing, good laboratory, good clinical practices, and product life cycle management pertinent to FDA-regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS), and general quality practices. • Develop, lead, and write position papers that define the 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 implementation and issues resolution. • Lead Quality Compliance activities with respect to TPMP readiness. • Participate and/or lead QMS audits and assessments. • 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 Assessments. • 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. • Maintain confidentiality of information acquired during audits and projects. We want you to have: • Bachelor's degree in a Physical Science, Engineering, or related field. • Minimum of 7+ years leadership experience in FDA and or FDA regulated quality systems and operations (pharmaceuticals, medical devices, and dietary supplements). Experience with product development preferred. • Experience interpreting, understanding, and implementing Quality Management System. • Experience with leading FDA Regulatory Inspections as a client (front room, back room, or program management) or as an FDA investigator. • 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 proven ability to collaborate with others. • Ability to considerately, independently, and persuasively provide critical 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 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 10-20% with this position. 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. Altria Client Services Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, sex, national origin, or other legally protected characteristic 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.