Lead Manager QMS - RJRT Quality Management
About the Job
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 with RJ Reynolds Tobacco Company—the second-largest U.S. tobacco company. The company's brands include Newport, Camel and Pall Mall.
This position will lead the development, maintenance and improvement of the Quality Management System (QMS) and serve as the on-site Quality Assurance lead. The applicable regulatory requirements at the assigned site will determine the specific duties and responsibilities assigned to this role.
Principal Duties and Responsibilities:
- Maintain the upper level QMS elements such as Quality Manual and Quality System SOPs
- Manage Audit activities, which include but are not limited to: client notification, audit plan and schedule development, audit questions and checklist development, conduct of opening/closing meetings and audit interviews, and preparation of audit reports
- Audit contract manufacturers and/or service providers to ensure QMS adequacy, acceptable quality limits (AQL) are achieved, and contractual requirements are met
- Plan and lead audits for adherence to FDA, GMP, and Risk management (i.e. HACCP) plans; provide final reports with audit findings and follow-up support
- Support/host regulatory inspections and external audits
- Perform managerial, administrative and Subject Matter Expert (SME) roles during regulatory inspections
- Perform technical quality work with limited direction from management that may include review/approvals specific to regulatory requirements (i.e., Major Deviations, Annual Product Reviews, CAPA investigations)
- Apply an extensive working knowledge of the manufacturing process and Pilgrim SmartSolve (PSS) to the Document Coordinator role, including PSS Administrator responsibilities, as applicable.
- Ensure appropriate development and consistency in the document training program
- Lead/support Quality, GMP and Regulatory Compliance teams and programs (i.e., CAPA, Non-Conformance/Planned Deviation, Change Control, Complaints, Pest Control, Calibration)
- Provide technical writing support, QMS edits, consulting, and investigation as required
- Lead, manage, and develop direct reports in a high performance culture via goal setting, coaching, performance evaluation, succession planning, and development plans
- Maintain understanding of QMS requirements and relevant regulatory requirements
- BS degree or higher with relevant experience (5+ yrs); OR
- Associate degree with relevant experience (7+ yrs); OR
- High School diploma or equivalent with relevant experience (9+ yrs)
- Extensive knowledge of QMS, GxP, ISO and Manufacturing processes applicable to the assigned site (i.e., ISO9001, ISO13485, 21 CFR 210, 21 CFR 211, 21 CFR 820)
- Experience working with Microsoft Office Professional Suite
- Management and development of direct reports
- Strong Quality Assurance background;
- Experience with Regulatory requirements specific to assigned site;
- Knowledge of Audit Process, reporting systems, and databases;
- Ability to apply standard quality theories, concepts and techniques;
- Ability to communicate effectively with all levels across the company; and
- Attention to detail
- Willingness to acquire and maintain appropriate quality and/or regulatory certifications for role (CQE, CQA, Six Sigma, auditor, etc.)
- Ability to work independently and make decisions with minimal oversight
- Results oriented, with the ability to prioritize and multi-task to meet Manufacturing and regulatory reporting deadlines
- Regular attendance at work
- 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.
Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.