Have 10 years of leadership experience in quality systems and operations with the FDA or in a FDA regulated environment? Have a passion for driving excellence and compliance in everything you do? If so, we want to speak with you! We are currently seeking a Manager, Regulatory Quality Compliance to join our Regulatory Quality Audits & Requirements department in Richmond, VA.
This role will work with multiple business partners to prepare for FDA Tobacco Product Manufacturing Practice (TPMP)’s. You will collaborate with quality, manufacturing, and product development personnel to evaluate their quality systems and product processes.
In this role, you will:• Generate TPMP gap assessments of existing processes and systems against Altria Quality Requirements (AQR) using multi-disciplined, multi-functional teams. Plan and conduct research on good manufacturing, good laboratory, good clinical practices, and product development requirements pertinent to FDA regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS) and general quality practices• Lead enterprise FDA Inspection Readiness Plans to support TPMP readiness activities. Develop proficiency in industry proposed TPMPs. Generate and lead project plans to address remediation plans. Generate metrics to track project progress• Develop, lead, and write position papers which define the rationale for TPMP response and interpretation• Conduct trend analysis and formulate management communications for emerging quality risks related to TPMPs• Craft and improve quality requirements and standards through independent research and interpretation of other FDA regulated industries and standards• Provide mentorship and recommendations to management on tobacco Manufacturing Practices (TPMP) implementation and issues resolution• Lead Quality Compliance activities with respect to TPMP readiness• Participate and/or lead QMS audits• Provide TPMP Quality Compliance support for Vendor and Supplier Management, including, but not limited to, Contract Manufacturing Organizations, Contract Labs, Quality Agreements, QMS infrastructure, and risk management• Advise on internal and external situations which may pose quality/compliance risks that may adversely affect business operations• Conduct 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• Lead or participate in corrective actions and programs designated to improve the quality and compliance posture of the organization• Maintain confidentiality of information acquired during audits
We want you to have:• Bachelor's degree in a Physical Science, Engineering or related field• Minimum of 10 years of leadership experience in FDA and or FDA regulated quality systems and operations (pharmaceuticals, medical devices, and dietary supplements). Experience in product development preferred.• Working knowledge of Data Integrity and product development related requirements.• Strong analytical and organizational skills• Strong written, verbal and presentation skills along with proven ability to collaborate with others• Ability to considerately, independently and persuasively provide critical and sensitive feedback to the most senior levels of management• Proficiency in conflict negotiation and resolution is preferred• Perform assignments in an independent and autonomous manner with minimal direct supervision• Able to utilize various computer software to include: Word, Excel, PowerPoint, and Outlook• Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods
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 them with opportunities for training, development, and advancement.