Senior Director, Regulatory Process and Compliance- Quality Assurance provides corporate leadership for governance, project management, and execution of corporate Quality Assurance and FDA compliance initiatives. Senior Director, Regulatory Process and Compliance also leads the vision and strategy for Quality Management Systems and ensures alignment with relevant regulations and corporate assumptions.
The incumbent maintains a strong credibility throughout the organization, leading change and driving compliance strategy both horizontally and vertically. This position requires the ability to motivate and lead cross-functional, departmental and external resources and requires a holistic view of the business which the incumbent uses to align and partner with others. The incumbent leads a proficient staff of technical professionals with accountability across multiple business areas and creates an environment that develops team members in technical knowledge, leadership dimensions and business insights.
Principal Duties and Responsibilities:
Provide leadership and direction for Quality Management Systems, Supplier Management processes and FDA compliance initiatives
Direct activities related to FDA Compliance Training
Interpret FDA regulations, develop assumptions related to current and future regulatory requirements, and ensure processes are developed and executed to effectively comply
Develop and implement strategies and processes required for FDA compliance
Provide guidance on critical topical areas associated with FDA compliance
Oversight of Supplier Audit, including External Vendor Audit for Clinical Studies and Laboratories
Create strategies for sharing regulatory compliance information throughout S&RA and corporate groups
Provide leadership and facilitation of corporate quality and regulatory processes, Post Implementation Reviews, and other collaborative compliance efforts
Partner with pillars and functions to ensure adequate, efficient and effective compliance processes
Provide leadership and talent development to ensure personnel meet their full potential. Ensure appropriate training and positioning for succession planning
4 year undergraduate degree in relevant field. MBA and/or CPA preferred
10 years of relevant experience
Understanding and ability to synthesize information within the Tobacco or similar category and cross-functional understanding of Operating Companies’ business processes and cultures with ability to lead harmonization
Ability to develop and implement strategies/processes across multiple Operating Companies and company functions. Ability to anticipate emerging issues and create results in a complex multi-functional environment
Expertise in quality and regulatory compliance background including a working knowledge of related processes, systems and requirements
Proven leadership ability, with strengths in collaboration, influencing and leading change. Experience managing professional staff
Track record of championing high performance talent development
Strong written and verbal communication abilities
Demonstrated capability to lead multiple projects / milestones simultaneously with solid collaboration skills
Possess a proactive work style and high sense of urgency
Conversant tobacco-relevant FDA quality and regulatory compliance
Proven leader with strategic approach
Project Management experience, Controls mindset, Quality and Regulatory Compliance background
Experience in tobacco category with strong working knowledge covering a range of functions with regulatory impact
About Reynolds American, Inc.
Reynolds American, Inc. is the U.S. parent company of R.J. Reynolds Tobacco Company; American Snuff Company, LLC; Santa Fe Natural Tobacco Company, Inc.; and R.J. Reynolds Vapor Company. Please visit our website www.reynoldsamerican.com for more information.