Assess compliance of documentation and data controls with FDA regulations, guidance, information security (e.g. ATO, FISMA) and standard operating procedures.
Evaluate completeness, and consistency and gaps in supporting documentation associated with testing activities and system documentation.
Identify deviation, inconsistencies from established processes and risks impacting regulatory decisions.
Conduct comprehensive data quality assessment to detect trends, data anatomies and performance variations in procedures and their potential impact on data quality.
Generate assessment records, gap analysis and final assessment and improvements report under the guidance of the QA Data Auditor Lead and Client Program Manager.
What You Will Need
Bachelor’s Degree, relevant experience may be substituted for formal education.
Minimum five (5) years of relevant experience in federal information systems management, data management and database administration.
Demonstrated ability to define data integration problems and analyze complex systems within regulatory or scientific domains.
Experience developing analysis plans, evaluating data quality, and information security compliance.
Strong knowledge of FDA regulations, data integrity principles (e.g., ALCOA+), and regulatory documentation standards.
Ability to assess system specifications and recommend improvements for implementation.
Excellent written and verbal communication skills, including status reports, technical reports and audit documentation.
Strong critical thinking and problem-solving capabilities in complex regulatory environments.
Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.
What Would Be Nice To Have
Certifications in database administration (e.g. Oracle\Microsoft DBA, RDMS), data management (I.e. CDMP-DAMA), Data Governance (e.g. DGSP or DCAM) or Data Quality (i.e. CDQP).
Experience supporting regulatory quality surveillance initiatives, data systems and data management practices.
Experience conducting internal audits or supporting regulatory inspections (e.g., FDA, ISO, GLP).
Knowledge of database systems used for laboratory data management (e.g., LIMS), scientific instruments and laboratory equipment.
Experience with data governance, quality frameworks, and process improvement methodologies.
Experience translating audit findings into operational and system-level improvements.
Exposure to advanced analytics tools to conduct research, evaluate data integrity and trends.
The annual salary range for this position is $65,000.00-$108,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
What We Offer
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include
Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Parental Leave
401(k) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus
About Guidehouse
Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.
If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.
Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.
