We are currently seeking a highly qualified Associate Manager, Quality Compliance to join our Regulatory Affairs department in Richmond, VA.
The successful candidate will be responsible for conducting quality audits of internal, supplier, and/or clinical related operations to evaluate the level of conformance to company standards and/or regulations. In addition to direct auditing related activities, the incumbent will be required to support FDA inspection activities and develop compliance assessments and trend analysis of emerging risk areas and formulating escalation communications to management.
The incumbent will be expected to apply a broad based knowledge of quality operations and 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.
Specific accountabilities include:
Planning, conducting and reporting the results of internal, supplier, and/or clinical related quality audits to departmental and operational management.
Planning and coordinating audit and project activities using multi-discipline / multi-functional teams.
Identifying and escalating internal and external situations which may pose quality/compliance risks that may adversely affect business operations.
Assisting in the development, implementation and continuous monitoring of objectives, procedures, tracking and trending mechanisms to ensure that management is consistently informed on the status and effectiveness of compliance activities.
Participating in the development of Altria-wide audit resources through training and/or mentoring to increase the overall organizational capability.
Conducting 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.
Evaluating situations to determine the potential impact.
Leading or participating in corrective actions and programs designated to enhance the quality and compliance posture of the organization.
Providing guidance and recommendations to management on Good Manufacturing Practices (GMP) implementation and issues resolution.
Maintaining confidentiality of information obtained during audits.Qualifications include:
A Bachelor's Degree in a Physical Science, Engineering or a related field.
A minimum of 8 years relevant experience in quality systems auditing and operations.
Direct FDA experience or quality/compliance experience in an FDA regulated industry (pharmaceuticals, medical devices and dietary supplements).
Detailed-oriented with strong analytical and organizational skills.
Strong written, verbal and presentation skills along with demonstrated 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.
The ability to perform assignments in an independent and autonomous manner with minimal direct supervision.
Ability to utilize various computer software to include: Word, Excel, PowerPoint and Outlook.
Audit and/or quality certification in ISO, ASQ CQE or CQM is desirable or ability to obtain an ASQC Quality Auditor certification within one year of obtaining this position.
Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods.
Ability to travel up to 50% 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.