Senior Manager - Quality Assurance, Data Integrity Officer

Senior Manager - Quality Assurance, Data Integrity Officer

The Senior Manager - 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 Senior Manager – 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 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, weekly DI awareness topics, and monthly reporting to the site leadership team. Collaborate with cross-functional teams for continuous improvement of processes to facilitate right first-time documentation.

OVERALL JOB RESPONSIBILITIES

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 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
• Conduct audits and gap assessments based on regulatory requirements and industry guidance as updated and issued from time to time
• 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

KNOWLEDGE, SKILLS AND ABILITIES:

Education

• Bachelor’s degree or higher in Chemistry, Biotechnology, Life Sciences, Engineering or related working experiences.

Experience

• 7 years in a regulated industry OR 5 years with related technical knowledge including data integrity related to computer systems / data related to manufacturing equipment, QC instruments, and support equipment/systems.
• Experience with quality control data, chromatographic systems, laboratory instruments, manufacturing equipment and quality management systems preferred.
• Knowledge of and experience with Data Integrity, Quality, Quality Control, Computerized Systems, Good Manufacturing Practice, Good Documentation Practice, Good Laboratory Practice, and other aspects of cGMP environments
• Demonstrated leadership experience over personnel, systems, and processes
• Experience working for a multi-national/multicultural organization is a plus

Knowledge &…