Director, Data Integrity

$150,000 - $150,000/Yr

Sharp Corporation - Allentown, PA

Full-time - Senior

Onsite - Allentown, PA

Professional, Scientific, and Technical Services

About the position

The Director, Data Integrity is responsible for leading and managing the organization's data integrity initiatives, ensuring the accuracy, consistency, and reliability of GXP data across computerized and paper systems. This role involves overseeing the development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, while enabling adherence to ALCOA+ principles. The Director will collaborate with various departments to ensure compliance and drive a Data Integrity Management program across multiple facilities.

Responsibilities

• Develop and lead a Data Integrity Management Program, defining objectives and scope, and developing/refining data integrity standards and procedures.
• Serve as a Data Integrity subject matter expert (SME) during regulatory inspections and train staff on ALCOA+ principles.
• Report to the VP Quality for Commercial Packaging US and serve on the global Quality Leadership team.
• Develop data integrity site leads to manage data integrity at a site level.
• Ensure risk-based methodologies are understood and implemented for data integrity management.
• Work closely with the Data Governance team to integrate data integrity into the overall data governance framework.
• Collaborate cross-functionally to clarify roles and responsibilities regarding data management and stewardship.

Requirements

• Bachelor's degree in IT, engineering, scientific discipline, or related field; Master's degree preferred.
• Minimum of 8 years of experience in data management, data governance frameworks, and data quality tools.
• At least 3 years in a leadership role within a pharmaceutical operation.
• Expertise in 21 CFR Part 11, EudraLex Annex 11, and GAMP standards for data integrity and validation of automated systems.
• Proven experience managing data integrity initiatives in a pharmaceutical organization.
• Excellent verbal and written communication/documentation skills.

Nice-to-haves

• Experience with computerized systems and adherence to ALCOA+ principles.
• Strong analytical skills with the ability to interpret complex data sets.
• Demonstrated history of influencing and motivating cross-functional teams.

Benefits

• Health insurance
• Dental insurance
• 401(k)
• Tuition reimbursement
• Paid time off
• Employee assistance program
• Vision insurance
• 401(k) matching