Senior Data Integrity Specialist

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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

• 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.

SUPERVISORY RESPONSIBILITIES

Moderate, including scheduling, oversight of assigned projects, and supporting Data Integrity Director as requested.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE

• Associate or bachelor’s degree is preferred with a minimum of four (4) years of direct Data Integrity experience.
• Cross-functional experience in three or more areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
• Experience in the pharmaceutical industry is required with good understanding of the drug and device process from regulatory filing and approval of drug applications as well as commercial manufacturing processes.
• Essential skills include: Exceptional documentation and interpersonal skills, including written and verbal communication; Excellent organizational and planning skills with strong critical thinking to analyze complex situations and discern critical issues; In depth knowledge of data integrity regulations, GxP Computer System Validation (CSV), industry accepted SDLC and qualification programs, and Part 11 requirements; Ability to multi-task, be transparent, reliable and deliver on commitments/ timelines; Strong sense of ethics, diplomacy and discretion; Experience in working in the matrix and challenging self and others to continuously learn and improve; Ability to work effectively with multicultural workforce with a team player attitude.