We are currently seeking a highly qualified Clinical Quality Manager to join our Regulatory Affairs department in Richmond, VA. The successful candidate will be responsible for creating and enhancing clinical quality requirements and standards for our network of Contract Research Organizations (CROs) and will work with multiple business partners to prepare and assure FDA inspection readiness. In addition, this role will conduct quality system gap assessments to evaluate clinical operations quality systems for conformance to requirements and then assist in the development and tracking of gap remediation plans.
Specific accountabilities include:
Leading Clinical Quality Management Reviews (summarizing quality audits, deviations and CAPA trends for Altria leadership and our Clinical Operations group). Presenting clinical quality updates at CRO and bioanalytical lab governance review meetings.
Evaluating and reviewing clinical trial deviation trends to ensure appropriate investigations are conducted.
Leading, developing, and managing CRO Quality Agreement responsibilities.
Developing audit schedules and conducting/coordinating supplier GCP/GLP audits including, CRO, clinical site, and bioanalytical audits. Reviewing supplier data integrity program.
Participating in quality management system (GLP, GCP) audits to oversee supplier audit practices.
Leading preparation of GCP and GLP- related inspections by regulatory authorities, including participation in the preparation of responses to external regulatory inspections.
Leading and coordinating assessment of Clinical Operations.
Leading or participating in corrective actions and programs designed to enhance the quality and compliance of the organization.
Escalating internal and external situations which may pose quality/compliance risks. Qualifications include:
A Bachelor's degree, or equivalent experience, in a physical science, engineering, or related field.
A minimum of 10 years of relevant experience in FDA regulated clinical quality systems and operations (pharmaceuticals, medical devices and/or dietary supplements).
Experience with providing FDA, ICH and other regulatory guidance to support clinical team's preparation for agency inspections.
Detail orientation; strong analytical and organizational skills.
Ability to tactfully, independently and persuasively provide critical and sensitive feedback to the most senior levels of management.
The ability to travel up to 30% throughout the year (domestic and international).
Altria is a Fortune 200 company, proud to call Richmond, Virginia our home. Our companies - which have been the undisputed market leaders in the U.S. tobacco industry for decades - include some of the most enduring names in American business: Philip Morris USA, the maker of Marlboro cigarettes, and U.S. Smokeless Tobacco Company, the maker of Copenhagen and Skoal. We also own John Middleton, manufacturer of Black & Mild cigars, Nat Sherman, a super-premium cigarette and cigar business and Nu Mark, an innovation company which makes e-vapor products like Mark Ten. We complement our total tobacco platform with Ste. Michelle Wine Estates, a collection of distinctive wine estates and maker of Chateau Ste. Michelle, and our significant equity investment in Anheuser-Busch InBev - the world's largest brewer.
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.