Company
Healthcare
SeniorDataIntegritySpecialist
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Data Integrity Specialist. Skills: Data Integrity, GxP, GMP, GDP, regulatory compliance. delivering subject matter expertise in GxP (GMP and GDP) to ensure compliance with data integrity standards. support the Data Integrity Governance program through assessment/remediation activities”
Industry & Context.
critical thinking to analyze complex situations and discern critical issues
normally required to sit at a desk or periodically go onto the shop floor
What They're Looking For.
Must Have
minimum of four (4) years of direct Data Integrity experience, Experience in the pharmaceutical industry is required, good understanding of the drug and device process from regulatory filing and approval of drug applications as well as commercial manufacturing processes, In depth knowledge of data integrity regulations, GxP Computer System Validation (CSV), industry accepted SDLC and qualification programs, Part 11 requirements
Nice to Have
Associate or bachelor’s degree is preferred, Cross-functional experience in three or more areas (i. e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc. ) is desired
What You'll Do.
delivering subject matter expertise in GxP (GMP and GDP) to ensure compliance with data integrity standards
support the Data Integrity Governance program through assessment/remediation activities
maintaining the Sharp US Commercial-wide Data Integrity governance system
ensuring that all regulatory and Sharp requirements are met comprehensively and promptly
communicating data integrity principles and training individuals at all levels within the organization
Provide day-to-day support for the governance
and implementation of activities related to the Data Integrity activities across Sharp US Commercial sites and in alignment with relevant governmental regulations and guidelines
and approving appropriate Sharp policies and procedures
coordinating all relevant activities between Quality
IT and other departments in relation to implementation
maintenance and change management of assigned programs
Support and manage remediation efforts
utilizing Quality Risk Management (QRM) based principles to identify risk and establish appropriate prioritization
Provide active support during regulatory agency and third-party inspections
Support knowledge transfer and training to departmental team specific to data integrity requirements
How You'll Work.
Team & Collaboration
Ability to build alignment with business partners including commercial operations, and manufacturing functional and site leaders; Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites; coordinating all relevant activities between Quality, IT and other departments
Communication Scope
communicating data integrity principles; training individuals at all levels within the organization; effectively communicate challenging goals & objectives; Exceptional documentation and interpersonal skills, including written and verbal communication
Process & Methodology
Ability to demonstrate project management focus, focus on execution of strategic decisions while balance conflicting priorities
Full Job Description
**SUMMARY:** The Sr. Data Integrity Specialist will concentrate on delivering subject matter expertise in GxP (GMP and GDP) to ensure compliance with data integrity standards. The position will support the Data Integrity Governance program through assessment/remediation activities and is responsible for maintaining the Sharp US Commercial-wide Data Integrity governance system, ensuring that all regulatory and Sharp requirements are met comprehensively and promptly. Additionally, the role involves communicating data integrity principles and training individuals at all levels within the organization. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The following is a list of minimum responsibilities related to the Senior Data Integrity Specialist position. Other duties may also be assigned. * Possess advanced understandings of GMP and GDP regulatory requirements regarding drug, device, and drug-device combination products. * Provide day-to-day support for the governance, management, coordination, and implementation of activities related to the Data Integrity activities across Sharp US Commercial sites and in alignment with relevant governmental regulations and guidelines. * Responsible for developing, reviewing, and approving appropriate Sharp policies and procedures (including safety rules and regulations) and coordinating all relevant activities between Quality, IT and other departments in relation to implementation, maintenance and change management of assigned programs. * Support and manage remediation efforts, utilizing Quality Risk Management (QRM) based principles to identify risk and establish appropriate prioritization. * Provide active support during regulatory agency and third-party inspections. * Support knowledge transfer and training to departmental team specific to data integrity requirements. **QUALIFICATIONS:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representati
Applying for this Senior Data Integrity Specialist role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about this company?
Real rants from real employees. Read before you apply.