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Director, Quality Assurance Auditor - Scientific & Reg. Affairs

Date: Feb 15, 2019

Location: Winston-Salem, NC, US

Company: RAI

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 Director Quality Assurance (QA) provides enterprise-wide leadership in establishing strategy, maintaining integrity and providing oversight of regulatory-related business processes, policies, and guidelines to assure FDA compliance.  The Director QA provides direction and is responsible for oversight of all audit engagement phases for Facility, Supplier and QA GxP Audits proactively identifying corporate risks and issues as part of the annual risk assessment process.  The Incumbent provides leadership and direction in the identification of potential process review opportunities, provides direction to staff who are involved in assessments for manufacturing facilities; suppliers of materials, components and services; and suppliers of services related to GxP contracts.  The Director QA provides leadership to staff including setting direction and execution activities to achieve integrated audit strategy; identifying on-going training needs based on current risk environment; measuring success and remediating, where necessary, and motivating / coaching staff for continued growth development.

 

Principal Duties and Responsibilities:

 

  • Lead, manage, and develop direct reports in a high performance culture via goal setting, coaching, performance evaluation, succession planning and development plans
  • Provide leadership and direction to staff who have multiple audits and departmental projects underway simultaneously.  Assures staff development by mentoring staff with focus on refining audit skills as well as overall business knowledge
  • Provide leadership and guidance of key processes in enterprise-wide non-manufacturing functions to ensure compliance with regulatory requirements
  • Provide leadership for the Quality Assurance and Procurement management processes related to direct material suppliers and contract manufacturers including supplier risk management, selection, qualification, audit, and corrective action
  • Develop, direct and maintain a comprehensive, annual strategic quality audit plan for ensuring Company compliance with regulatory requirements for GMP, GCP and GLP activities
  • Develop solid business partnering relationships with audited parties to stay informed regarding current business environment changes/ trends in order to assess potential impact to controls and process improvement opportunities as well as alignment of audit strategy
  • Proactively identifies corporate risks and issues as part of the annual risk assessment process
  • Provide leadership in the development of audit scope, identification of key objectives, related risks, and the control activities/environment in place to mitigate these risks
  • Provide management oversight of consulting auditors.  This includes attaining appropriate skill sets to meet audit requirements, appropriate oversight throughout the audit, budget reviews and monitoring of metrics
  • Ensure effective and timely communication of audit issues to the audited party
  • Investigate and resolve complex technical and compliance issues, supporting proposals for resolution
  • Analyze business processes to identify key objectives and optimal level of control / risks
  • Assure and lead standardization across the enterprise on the implementation of relevant business processes to promote consistency and support continuous improvement
  • Proactively identifies value-added departmental projects

 

Education:

Minimum BS degree; area of focus in quality, scientific or engineering preferred

 

Experience:

  • Minimum of 10 years of experience in a regulated industry in a quality leadership role with broad scope and accountabilities
  • Strong regulatory compliance knowledge including auditing standards for GLP, GCP and GMP 
  • Audit experience in a regulated industry
  • Quality experience in a regulated environment

 

 

Required Skills:

 

  • Excellent analytical, problem solving and decision making skills
  • Demonstrated ability to develop strategies, anticipate emerging issues and create results in a complex multi-functional environment
  • Excellent organizational, personnel management and project management skills with the ability to manage multiple projects simultaneously and adapt to rapidly changing priorities
  • Excellent interpersonal, oral, and written communication skills
  • Demonstrated leadership abilities and strong representation of company and departmental core values
  • Demonstrated ability to influence and collaborate with internal and external resources at all levels of the organization
  • Demonstrated ability to identify obstacles and problems and define resolutions that meet company objectives
  • Knowledge of and ability to apply Quality tools to drive Continuous Improvement
  • Ability to implement policy and systems across matrix and enterprise organizational structures
  • Excellent analytical, problem solving and decision making skills
  • Ability to interpret regulations and policies, and to communicate operational requirements with the organization
  • Experience working with Microsoft Office Professional Suite

Preferred Skills:

 

  • Certified Quality Auditor Certification
  • Broad understanding of the tobacco category and relevant company experience and broad based knowledge of functional areas of Operating Companies
  • Experience managing people/processes in a regulated environment
  • Strong regulatory compliance background including a working knowledge of FDA systems and reporting requirements
  • Proven track record in leadership, change management and cross-functional project management
  • Knowledge of statistical methods utilized to evaluate performance
  • Knowledge of Lean and Continuous Improvement principles
  • Ability to be self-directed and proactive
  • Ability to identify, lead and support initiatives that create change

 

Please note:  Extensive domestic and international travel will be required for this position, particularly in the first year.

 


Compensation/Targeted Bonus

  • Competitive Annual Salary
  • Targeted Annual Bonus
  • Relocation assistance available for those who qualify.

 

Benefit Summary

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.

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Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.

Telephone: 262-439-1893

Email: TalentAcquisition@RJRT.com


Nearest Major Market: Winston-Salem

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