We are currently seeking a qualified Quality Manager - Contract Lab Data Integrity to join the Analytical Sciences Department located in our Center for Research and Technology in Richmond, VA. Analytical Sciences uses external contract labs for various projects in support of the enterprise. This position will be responsible for establishing and executing programs to ensure the integrity of data provided by external contract labs.
Specific accountabilities include:
*Serving as technical leader in developing and implementing processes to review and ensure the quality and integrity of analytical data generated by external contract labs. *Independently leading and conducting in-depth audits of external contract lab analytical method development activities, in-use analytical methods and quality system practices. *Using analytical method expertise to track and assess the impact of method deviations, OOS investigations, CAPA's and audit findings/observations on external contract lab data integrity. *Serving as company lead with external contract labs to identify and correct analytical method or process issues related to unacceptable data. *Conceiving, implementing and using systems to identify, monitor and report key metrics for external contract labs; and correlating those metrics with impact to data integrity. *Independently developing and implementing appropriate quality system documentation for data quality management of external contract labs.Qualifications include:
*A B.S. in chemistry or other scientific discipline, M.S. in chemistry preferred. *A minimum of 8 years of laboratory experience in a Quality Assurance management role in biotech, pharmaceutical or other FDA regulated industry. *Demonstrated knowledge of analytical method development and validation and data review. *Demonstrated experience conducting technical, quality and data audits of laboratory operations in compliance with recognized standards such as ISO and FDA GMPs. *Prior experience interacting and managing relationships with contract labs. *Working knowledge of GLP's as well as ICH/FDA guidelines related to product stability studies. *Excellent communication skills and ability to work independently. *Ability to travel domestically and internationally ~20% of the time.
Altria Group is a FORTUNE 200 company whose 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 owns the premier tobacco companies in the United States including Philip Morris USA, U.S. Smokeless Tobacco Company, John Middleton and Nu Mark. The companies' brands include Marlboro, Copenhagen, Skoal, Black & Mild, MarkTen and VERVE. Altria also owns Ste. Michelle Wine Estates, one of the country's top premium wine producers, and Philip Morris Capital Corporation, an investment company.
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. 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 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.
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.