Reference #: JR109680
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.Temporary FDA Validation ManagerWe are looking for an experiencedValidation Managerto develop and grow our FDA IT Compliance and Validation practice. The candidate will work with top global pharmaceutical and medical device firms to ensure unparalleled validation services.The ideal candidate will be responsible for:
Assisting in scoping validation services
Assist in the Writing proposals and validation Statements of Work
Provide FDA IT Compliance guidance and awareness training to project teams
Assist with the development of system requirements and specifications to ensure validation/Part 11 requirements are met
Evaluate proposed changes to validated computer systems and recommend level of validation activities required
Coordinate audits of internal computer systems validation activities, protocol and procedures, and prepare responses
Identify and qualify all computer systems which impact GxP operations using a risk based methodology
Develop computer systems validation plans, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
Deep understanding of test plans, test scripts and user acceptance tests and the management of the execution of test plans
Act as a CSV Lead for all validation projects
Execute or oversee the execution of validation plans and validation documents
Perform project management activities for CSV process within the scope of an overall system project
Work with overall project manager to include validation activities in implementation timelines
Manage internal CSV resources to facilitate completion of qualification activities
Develop validation summary reports
Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systemsEducation and Experience
3 - 5 years of CSV experience in FDA regulated industry or in consulting to FDA-regulated industries
BS degree in Computer Science, MIS, Life Sciences or Engineering is recommended
Excellent understanding and experience with industry regulations, standards and guidelines, including GxP, 21 CFR Part 11, GAMP-5 and optionally EMA and the new CSA guidelines
Experience in the review, evaluation and testing of systems to ensure compliance with the FDA Electronic Records/Electronic Signatures regulation and 21 CFR
Excellent interpersonal, communication, organizational, and project management skills. Excellent presentation and writing skills. Supervisory/leadership experience preferred.At RSM, we offer a competitive benefits and compensation package for all our people.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.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 me tal 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; US Military/Veteran status; 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 [email protected] 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.RSM will consider for employment qualified applicants with arrest or conviction records in accordance with the requirements of applicable law, including but not limited to, the California Fair Chance Act, the Los Angeles Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance. For additional information regarding RSM's background check process, including information about job duties that necessitate the use of one or more types of background checks, click here.At RSM, an employee's pay at any point in their career is intended to reflect their experiences, performance, and skills for their current role. The salary range (or starting rate for interns and associates) for this role represents numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, location, etc. As such, pay for the successful candidate(s) could fall anywhere within the stated range.
Compensation Range: $104 - $156 per hour |RSM is an equal opportunity/affirmative action employer. Minorities/Females/Disabled/Veterans.