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FDA Validation and IT Quality Director

The ERP and Automation Risk Consulting practice, assists with various consulting, internal, and external audit clients by bringing in-depth ERP, automation, and data analytics skills where needed. The practice performs security and controls designs/assessments, complex data analytics, GRC automation/implementation, security role design, security managed services, segregation of duties assessments, as well as ERP implementation risk reviews.

Scope of Services:

• The ERP Risk Advisory Consulting practice supports primarily mid-market clients across a multitude of industries who are currently operating on or plan to implement D365, Oracle, Workday, SAP, etc, suite of solutions.
• The practice helps our clients manage risk via various complex projects ranging from configuration review, controls testing, pre- and post- implementation risk assessments, segregation of duties analysis, GRC automation, and security vulnerability testing.
• In addition to supporting client-facing projects, the practice is continually seeking to grow our in-house capabilities via innovative initiatives including robotic-process automation (RPA), data analytics, and development of diagnostics tools.

Your responsibilities:

• Lead FDA validation practice for US and Canadian markets, within the risk consulting practice of RSM. Extend capabilities to our global member firms in an on-demand model. FDA Validation services includes would include assisting our clients that need to be in compliance with these federal requirements no matter what industry they are operating.
• Work with Risk leadership to first focus on identifying client targets based upon RSM's current account footprint and industry specific go to market strategies. At the same time build a practice growth model that will outline resource needs, resource training development and marketing needs.
• Continue to operate current practice working with the team to assess client opportunities and manage proposal, contract and engagement risk.
• Develop broad service offerings for clients including performing validation strategy assessments focusing on risk, cost, visibility and effectiveness; developing validation strategy master plans, validation SOPs, implementing enabling technology and execute validation testing.
• Develop an optimized delivery structure that will include determining the mix of resources both on, near and offshore as well as enabling delivery technology to ensure competitive pricing.
• Develop our offshore resource model working with USI leadership.
• Responsible for engagement contract development planning, economics, resource management, etc.
• Work cohesively within the RSM culture to facilitate client introductions and extend other RSM value added services.

Experience

• 12+ years' experience with FDA, GxP, GMP IT validation requirements
• Bachelor/ Master degree in Engineering/Science or in relevant IT field
• Demonstrated SME level knowledge of process validation and lifecycle management concepts, standards and GxP regulations.
• Strong technical experience in successful management of complex process validation projects is required.
• Experience with common life-science applications such as SAP, Oracle, Dynamics, & NetSuite
• Experience with FDA validation software
• Experience with FDA audits, SOX/public companies
• Experience in the life-science industries

At RSM, we offer a competitive benefits and compensation package for all our people. We support and inspire you to prioritize your wellbeing by delivering personalized, holistic programming for your physical, emotional, financial and community wellbeing. RSM has a generous time off policy with at least 14 paid holidays, wellbeing days and associate and above access to self-managed time off. We offer flexibility in your schedule, empowering you to balance life's demands, while also maintaining your ability to serve clients. Learn more about our total rewards at .

RSM is proud to be an Affirmative Action and Equal Employment Opportunity employer. We are proud to provide our employees with tools to assist them in being successful in achieving both personal and professional goals. We welcome and support all our employees to thrive in an environment free of discrimination and harassment. As an Affirmative Action and Equal Opportunity Employer all applicants will receive consideration for employment as RSM does not tolerate discrimination and/or harassment based on race; color; creed; sincerely held religious beliefs, practices or observances; sex (including pregnancy or disabilities related to nursing); gender (including gender identity and/or gender expression); sexual orientation; HIV Status; national origin; ancestry; familial or marital status; age; physical or mental disability; citizenship; political affiliation; medical condition (including family and medical leave); domestic violence victim status; past, current or prospective service in the US uniformed service; pre-disposing genetic characteristics or any other characteristic protected under applicable federal, state or local law.

Accommodation for applicants with disabilities is available upon request in connection with the recruitment process and/or employment/partnership. RSM is committed to providing equal opportunity and reasonable accommodation for people with disabilities. If you require a reasonable accommodation to complete an application, interview, or otherwise participate in the recruiting process, please call us at 800-274-3978 or send us an email at .

RSM does not intend to hire entry level candidates who will require sponsorship now OR in the future (i.e. F-1 visa holders). If you are a recent U.S. college / university graduate possessing 1-2 years of progressive and relevant work experience in a same or similar role to the one for which you are applying, excluding internships, you may be eligible for hire as an experienced associate.