Quality Assurance & Quality Control, Quality/Risk Management, Regulatory Compliance, Research & Development
4 Year Degree
We are currently seeking a highly qualified Manager, Quality Requirements to join our Regulatory Quality Compliance department in Richmond, VA.
The successful candidate will be responsible for creating and enhancing quality requirements and standards through independent research and interpretation of other FDA regulated industries and standards. This position will also work with multiple business partners to prepare and assure FDA inspection readiness. In addition, this role will conduct quality system gap assessments to evaluate the ability of their quality systems to conform to requirements and then assist in the development and tracking of gap remediation plans. In addition to the quality requirements related activities, the incumbent will be required to assist in developing and managing a global change management framework. Further areas of participation will include metrics development, trend analysis and formulating escalation communications for emerging quality risks 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 and conducting research on good manufacturing and good laboratory practices pertinent to FDA regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS) and general quality practices. Generating gap assessments of existing processes and systems against AQR using multi-discipline, multi-functional teams.
Leading FDA Inspection readiness activities for the enterprise. Managing FDA inspection infrastructure and continually improving the processes.
Coordinating Quality Compliance activities with respect to FDA regulatory submissions.
Participating in QMS audits.
Assisting in the development and management of global change control processes and procedures to support product life cycle management.
Providing Quality Compliance support for vendor and supplier management, Including, contract manufacturing organizations, contract labs, quality agreements, QMS infrastructure and hazards analysis.
Escalating internal and external situations which may pose quality/compliance risks that may adversely affect business operations.
Participating in the development of Altria-wide quality roll-out and training of new AQR content through training and/or mentoring to increase the overall organizational capability.
Conducting analyses, consulting and assessments of various operations and processes by applying your knowledge and judgment in areas where you may have little to no previous work experience.
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 tobacco manufacturing practices 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 10 years relevant experience in FDA regulated quality systems and operations (pharmaceuticals, medical devices and dietary supplements).
Detail orientation and 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.
Proficiency with various computer software to include: Word, Excel, PowerPoint and Outlook.
Certification in ISO, ASQ, CQE or CQM is desirable or ability to obtain an ASQ Quality Auditor/Management certification within one year of obtaining this position.
The willingness to work during non-core hours as required to assess multiple shifts and operations spanning lengthy periods.
Ability to travel up to 40% 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.