Reynolds American Incorporated is positively transforming the tobacco industry. We’re a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are redefining the ways adult tobacco consumers enjoy tobacco in the 21st century.
When other companies talk about growth, they only talk about size. At RAI, we focus on the growth of our people. We take pride in each other’s growth and well-being throughout our careers. We invest in your career and total well-being because we know our companies succeed when our people thrive.
At the RAI companies, you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.
This position is within Reynolds American Services Company—a subsidiary that provides support services, including compliance, HR, law, finance, information management, and more to all of the subsidiaries of RAI.
The Senior Manager QMS is responsible for providing enterprise leadership in Quality Assurance compliance efforts under applicable regulations (and/or draft) while demonstrating in-depth knowledge and understanding of quality management system (QMS) requirements, regulatory, and manufacturing processes. Individuals in this position will be responsible to identify, assess and incorporate industry best practices to assure QMS requirements are consistently achieved and act as a key resource to develop strategy and lead efforts to ensure compliance. The Senior Manager QMS may be responsible for managing direct reports and/or contract services and will work closely with Operations and other business stakeholders. The Senior Manager QMS may also be responsible for ownership and administration of the applicable E-tool, developing and maintaining governance processes for regulatory training, and/or performing QA review of validation documentation.
Principal Duties and Responsibilities:
Lead, manage, and develop assigned direct reports, as applicable, in a high-performance culture via goal setting, coaching, performance evaluation, succession planning, and development plans, as required
Maintain in-depth knowledge and understanding of quality management system requirements associated with QMS standards and relevant regulatory requirements; interpret and provide guidance
Identify, assess and incorporate industry best practices to assure compliance with FDA and applicable external US regulatory requirements and applicable guidance documents
Develop strategy and lead cross functional teams for new compliance processes and changes to existing processes to meet standards for regulatory compliance; facilitate documentation and capture of records
Act as key QMS compliance liaison with other functional departments, consultants and contract services
Monitor and assess business areas for compliance; analyze and report regulatory and/or quality metric trends and act as a key resource regarding quality and compliance issues
Develop and/or revise enterprise SOPs, guidance documents, and supporting documentation to ensure robust processes are in place to support compliance
Maintain a thorough knowledge of appropriate SOPs, applicable regulatory requirements and guidance documents
Support regulatory agency activities including inspections, inquiries, notifications, and other activities as required
Specific accountabilities may include one or more of the following:
Perform QA review of validation protocols/summaries, business readiness assessments, requirements risk assessments, and business process mapping for validation relevant assets and software systems
Perform as Data Owner for E-tool, inlcuding assuring the e-tool adequately facilitates relevant business processes in a validated state and with regard to change control
Manage regulatory training processes and act as training compliance liaison with other functional departments, consultants, and contract services
Manage and maintain governance and monitoring processes for regulatory compliance in assigned area of responsibility
BS degree with relevant experience (5+ years), or Associate degree with relevant experience (6+ years), or High school diploma or equivalent with relevant experience (7+ years
Minimum of 5 years of experience in Quality Assurance/Quality Control environment with minimum of 3 years of progressive leadership experience in a regulated industry
Strong regulatory compliance background including working knowledge of quality system requirements for manufacturing and regulatory processes (i.e., Complaints, CAPA, Document Management, Calibration, Equipment Qualification, Change Control, Non-Conformance, HACCP, Training, Validation)
Knowledge of applicable FDA regulatory standards and training requirements
Experience managing projects and/or project teams and working with consultants/contract personnel
Leadership ability to manage multiple projects and resources
Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and manage tasks through teamwork
Advanced level of written and verbal communication skills with the ability to read technical procedures or regulations and write reports and required documentation.
Systems aptitude, data techniques, and analytical skills
Problem solving and continuous improvement techniques
Strong adherence to process and protocol
Organization and time management skills
Attention to detail
Ability to work proficiently with Microsoft Professional Office Suite, quality data systems, and essential computer applications
Strong interpersonal skills with ability to collaborate with business partners
Demonstrated technical leadership skills in applicable area(s)
Ability to work independently and make decisions with minimal oversight
Certification related to FDA regulatory compliance and quality; or willingness to acquire relevant certification
Understanding of the Family Smoking Prevention and Tobacco Control Act, proposed TPMPs, and deemed tobacco products
Ability to solve practical problems in situations where only limited standardization exists
Experience managing people/processes within a GxP Quality System with thorough knowledge of cGMP regulations and standards (21CFR211, 21CFR820, EMA, ISO 13485, CE Marking and ICH guidances)
Ability to solve practical problems in situations where only limited standardization exists
Travel may be required.
Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
Our company offers very competitive compensation and benefit plans, including:
401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation. Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
Comprehensive health- and welfare-benefits package
Eleven paid company holidays annually, plus a generous paid vacation plan based on length of service
Company-paid sick and personal days, funeral leave and jury duty leave
Confidential personal financial counseling service
On-site health clinics and fitness centers
A matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
Health-care advocacy service
Volunteer service opportunities
Federal credit union membership through Allegacy Federal Credit Union
Extensive training opportunities
ABOUT OUR ORGANIZATION:
Reynolds American Inc. is an indirect, wholly owned subsidiary of British American Tobacco p.l.c., and the U.S. parent company of R. J. Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; Niconovum USA, Inc.; Niconovum AB; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; and Reynolds Brands, Inc..
Reynolds American Inc. and its affiliated companies is an Equal Opportunity / Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Our organization offers a level of challenge, responsibility and creativity for motivated employees that stands apart from the crowd.
We are also committed to employing a diverse workforce and valuing different perspectives, experiences and talents to maximize the company's potential for successfully achieving its business objectives.
Internal Number: 13206
About Reynolds American
Reynolds American Inc. is positively transforming the tobacco industry. We’re a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are rede?ning the ways adult tobacco consumers enjoy tobacco in the 21st century. Our companies have a diverse portfolio of innovative products for adult tobacco consumers. These products are the collective vision of our scientists, researchers, marketers, and business development teams. They are designed not only to address the new tastes and preferences of adult tobacco consumers, but also to rede?ne what it means to enjoy tobacco.
Reynolds American Inc. is the US parent company of R.J. Reynolds Tobacco Company, American Snuff Co., Santa Fe Natural Tobacco Company, Niconovum AB and USA, R.J. Reynolds Vapor Company, RAI Innovations Company, Kentucky BioProcessing Inc., RAI Trade Marketing Services Company, and RAI Services Company.