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Manager, Regulatory Quality Compliance

Company: Altria
Location: Richmond
Posted on: June 14, 2019

Job Description:

Do you have a passion for driving excellence and compliance in everything you do? How would you like to be part of a company that is on the forefront of changing the future of an entire industry? If you answered yes, then come join Altria!

Our companies have a long history of leading the industry and the future of our industry is about innovation, harm reduction and informed consumer choice. That s why Altria is investing in a portfolio of new products that satisfy changing preferences and have the potential for lower risk. Through product innovations, we strive to give consumers the choices they want today and develop new technologies for tomorrow.

This is where you come in. We are currently seeking a highly qualified and energetic Manager, Regulatory Quality Compliance to join our Regulatory Quality Compliance department in Richmond, VA.
You will work with multiple business partners to prepare for potential for FDA Tobacco Product Manufacturing Practice (TPMP) s. You will be working with quality and manufacturing personnel to evaluate their quality systems and product processes to meet those requirements.

In addition to the TPMP readiness related activities, you will be required to assist in leading enterprise-wide Quality related project plans. You will be responsible for crafting and improving quality requirements and standards through independent research and interpretation of other FDA regulated industries and standards. Further areas of participation will include metrics development, trend analysis and formulating escalation management communications for emerging quality risks related to TPMPs.

You will be expected to apply a broad based knowledge of quality operations and direct FDA related regulatory compliance in order to assist in the development, execution and assessment of proposed corrective action plans and remediation projects to ensure that quality gaps are closed in a timely and acceptable manner. You should also have working knowledge of Data Integrity related requirements.
You will:

  • 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, and good clinical practices pertinent to FDA regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS) and general quality practices.
  • Develop proficiency in industry proposed TPMPs. Lead enterprise TPMP readiness activities. 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.
  • 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 Hazards Analysis
  • Escalate 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 obtained during audits You 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)
    • Strong analytical and organizational skills
    • Strong written, verbal and presentation skills along with proven ability to collaborate with others
    • Ability to tactfully, 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 Altria is a Fortune 200 company, proud to call Richmond, Virginia our home.

      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. And we have 35 percent ownership of JUUL Labs, Inc., the nation s leading e-vapor company. 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.

      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.

      Each Altria company is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, sexual orientation, disability, gender identity, protected veteran status, or other protected class. Associated topics: business, company, corporate attorney, court, courtroom, internal, legal affairs, legal department, llp, market

Keywords: Altria, Richmond , Manager, Regulatory Quality Compliance, Executive , Richmond, Virginia

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