FDA Validation and IT Quality Director
Company: Rsm Us Llp.
Location: Boston
Posted on: April 30, 2024
Job Description:
FDA Validation and IT Quality Director page is loaded FDA
Validation and IT Quality Director Apply locations Philadelphia San
Francisco Boston time type Full time posted on Posted Yesterday job
requisition id JR104146 We are the leading provider of professional
services to the middle market globally, our purpose is to instill
confidence in a world of change, empowering our clients and people
to realize their full potential. Our exceptional people are the key
to our unrivaled, inclusive culture and talent experience and our
ability to be compelling to our clients. You'll find an environment
that inspires and empowers you to thrive both personally and
professionally. There's no one like you and that's why there's
nowhere like RSM.FDA Validation and IT Quality DirectorThe 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 industriesAt 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
https://rsmus.com/careers/working-at-rsm/benefits .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 careers@rsmus.com . -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.Compensation Range: $144,500 - $308,200
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Keywords: Rsm Us Llp., Malden , FDA Validation and IT Quality Director, Executive , Boston, Massachusetts
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