Quality Assurance, Data Integrity Officer

The Quality Assurance - Data Integrity Officer (“DIO”) is responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. Generally, this requires implementing, as appropriate, and overseeing systems and processes to ensure complete, consistent, enduring, and accessible data is attributable, legible, contemporaneously recorded, original or a true copy, and accurate.

The Quality Assurance – Data Integrity Office (DIO) will implement procedures, training and oversight aligned with corporate policies and global regulations to ensure the integrity of data generated to support manufacturing and testing processes. This role is responsible for all site DI Plan(s) and will collaborate across functions and sites to ensure full compliance are maintained.

Additionally, the Quality Assurance, DIO will serve as an active member of the site Quality Leadership Team and the Global Corporate DI Network and will implement DI practices and procedures to meet regulatory requirements. Coordinate routine DI Surveillance, and monthly reporting to the site leadership team. Collaborate with cross functional teams for continuous improvement of processes to facilitate right first-time documentation.

• Provide oversight for governance, management, and coordination of activities related to risk assessment, utilizing Quality Risk Management (QRM) principles, such as Failure Mode Effects Analysis (FMEA)
• Oversee remediation plans, retrospective assessments, and responses to regulatory audit findings related to Data Integrity
• Conduct self-inspection audits and gap assessments based on regulatory requirements and industry guidance as updated and issued from time to time
• Facilitate risk assessments for new and existing equipment and systems and provide strategic direction for remediation.
• Develop, own, and update procedures as necessary to ensure clear direction and understanding of Data Integrity principles and requirements.
• Leads Data Integrity training to ensure awareness and compliance to Data Integrity regulatory and program requirements.
• Support the change control and deviation management processes with respect to potential Data Integrity impact and ensure appropriate implementation actions are carried out to maintain compliance.
• Serve as the point person during client and regulatory inspections for DI.

• Confirm new and existing equipment and instruments are appropriately validated, when appropriate, to protect data and ensure activities can be audited and reviewed at appropriate intervals
• Oversee the selection, validation, and implementation of software used for the generation of cGMP data
• Assess training program and materials for adequacy to educate employees on expectations related to Data Integrity and conduct or oversee training, as appropriate
• Comply with applicable regulations and guidance, including, but not limited to, 21 CFR Parts 11, 210, and 211, and FDA Data Integrity guidance
• Reviewing data generated through batch releases and analytical data associated with ANDA submissions be compliant with Data Integrity requirement.