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Associate Manager Regulatory Quality Compliance QMS

Altria Richmond, Virginia
manager regulatory compliance tobacco compliance product development regulatory data design a&r inspection lead data integrity
February 15, 2023
Altria
Richmond, Virginia
FULL_TIME
Overview:


Want to develop and manage compliance activities to support Product Development in meeting Quality requirements for Premarket Tobacco Product Applications (PMTA) and Modified Risk Tobacco Product Applications (MRTPA) submission and inspection readiness within Regulatory Quality Compliance? If you have a bachelor's degree along with five plus years of relevant experience in Quality and Product Development, or Technology, Sciences, Regulatory Affairs, we want to speak with you!
We are currently seeking an Associate Manager Regulatory Quality Compliance QMS. This position will lead and/or support RQC compliance-related projects, strengthen data integrity, and improve the culture of quality.



What you will be doing:


  • Developing product development related processes and documentation to support project and compliance-related activities.
  • Conducting independent quality reviews and approvals of the design and development results as part of the design review team and assuring projects are compliant with established quality requirements.

  • Communicating clearly regarding projects/activities to ensure alignment on expectations, timing, and next steps.

  • Developing communications that deliver value and provide insights from data analysis, observations, and experience.

  • Leading quality audits of internal or supplier operations to evaluate level of conformance to company and regulatory standards

  • Leading risk assessments to provide recommendations to work teams.

  • Leading cross-functional teams in creation of remediation plans to address risks identified.

  • Independently monitoring data integrity progress to identify trends or deviations, taking steps to find root cause and documenting corrective actions.

  • Providing metrics, reporting and management updates as necessary.
  • Participating on cross-functional project teams and activities to support Product Development initiatives for new products including QMS generation and pre-approval inspection readiness.

  • Providing expertise and guidance in developing internal policies and interpreting Quality requirements to assure compliance goals are met.

We want you to have:

  • Bachelor's degree is required

  • 5+ years of relevant experience in Quality and Product Development, or Technology, Sciences, Regulatory Affairs. Medical device and/or Pharma experience preferred. Knowledge of Quality by Design principles and design control preferred.

  • Experience with Microsoft Excel, PowerPoint, Word, or Visio are preferred. Candidates with project management and/or data analysis experience are preferred.

  • Demonstrated problem-solving; analytical, planning, and organizational skills are required.

  • Excellent written and oral communication skills; proficiency in developing presentation materials; presenting information and ideas to varying levels within an organization.

  • Ability to perform duties within a general office environment. Position requires employee to be located in Richmond, Virginia with limited travel to manufacturing facilities (including suppliers).

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.

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