Senior Specialist, SOP & CAPA

Altria Client Services

Richmond, Virginia

5/31/2019 5:47:28 AM

19093BR

Regulatory Sciences

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Altria Group is a FORTUNE 200 company that holds diversified positions across tobacco, alcohol, and cannabis. Altria’s mission is to own and develop financially disciplined businesses that are leaders in responsibly providing adult tobacco and wine consumers with superior branded products.

Altria Client Services’ role is to provide high-quality services to the Altria family of companies. In support of that mission, we are currently seeking a Senior Specialist, SOP and CAPA to join our Science Operations team in Richmond, VA. Your role will be to develop and manage the Science Operations SOP and CAPA program in support of study execution.

You will:

* Manage the Clinical Research and Analytical Sample/Data Management SOP life-cycle, infrastructure and associated department training requirements.
* Develop, deliver and track SOP training for Science Operations.
* Serve as Document Control Coordinator (DCC) for QMS document approval and management.
* Serve as the Science Operations CAPA Coordinator. Develop and manage CAPA coordination activities including CAPA initiation, investigation, resolution within the TrackWise tool environment.
* Participate in the preparation of audit or FDA inspections. He/she also coordinates the Clinical Documentation responses to questions or observations or other projects as designated by a manager.

Specific Skills

You have:

* Bachelor's degree required; Advanced degree preferred.
* 3+ years of experience in clinical trials and SOP writing. Experience with document control ALCOA requirements (Attributable, Legible, Contemporaneous, Original and Accurate).
* 3+ years of experience with Quality Management Systems including CAPA coordination process.
* Knowledge of FDA tobacco product applications/regulations, ICH guidelines, GCP practices. Awareness and knowledge of applicable clinical research regulatory requirements (Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines)
* Proficiency in Microsoft office products and professional writing skills.
* Understanding of regulatory document review. Overall willingness to learn the tobacco industry and the growth of regulations relating to clinical research.
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; and a 45 percent ownership of Cronos Group, a leading Canadian cannabis 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.

Altria Client Services’ role is to help Altria Group and its operating companies responsibly meet their business goals by providing the high-quality services they require in a financially disciplined way. We believe in developing the leadership potential of our employees by providing 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 deferred profit sharing and incentive compensation programs as well as a relocation assistance package.

NOTE*

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.



Richmond, VA - Virginia



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