Director, Computer System Validation & Data Integrity

Nature and Scope

The Director of Computer System Validation and Data Integrity (DI) will lead a team to oversee project management and execution activities related but not limited to GXP computer systems and GMP software implementation projects across American Regent. The incumbent is responsible to ensure the validation guidelines are adhered to across all sites and systems are compliant with regulatory requirements. Responsible to work with management, functional areas, Quality departments and outside vendors as necessary to ensure prompt completion of projects through proper allocation of workload and resources, prioritization of tasks, and prompt and accurate communication to project leadership.

Accountable for creating and organizing short-term and long-term goals and plans that will ensure the continued improvement and growth of GxP Computerized Systems.

Develops organizational strategies in line with ARI goals. Responsible for preparing reports to present to management detailing the activities and progress of the department. 

The incumbent will also build and keep the necessary personnel resources, tools, and infrastructure to execute these responsibilities. This includes, but is not limited to hiring, training, and supporting the necessary staff to perform and/or appropriately delegate activities needed for successful system implementation and administration while ensuring adherence to Corporate Compliance Policies, regulatory requirements, and industry best practices.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Provide strategic leadership and direction for the GxP IT systems and DI programs. Create and organize short- and long-term goals for the department, which are in alignment with ARI’s business strategy.
• Monitor and interpret regulatory changes and industry trends related to computer system validation and DI.
• Provide constant support to the organization through, planning, and prompt execution of projects required by the business.
• Oversee the planning, execution, and documentation of computer system validation activities, including IQ/OQ/PQ protocols and reports.
• Ensure the company’s DI practices follow current regulations and industry standards.
• Prepare for and support regulatory inspections and audits.
• Conduct risk assessments and ensure proper controls are implemented.
• Establish weekly, monthly, quarterly, and annual performance reports on projects as needed to support the business.
• Provide effective leadership including individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating team members of the functional area.
• Assure adequate staffing to support all projects.

• Analyze the competency of personnel and accordingly selects them for projects. Reallocates or rotates tasks depending on the availability of the personnel and create training opportunities. Alternately, assign added responsibilities to personnel to complete projects on schedule.

• Aid in the training of new and existing staff to ensure that they are well versed with the procedures needed for projects.
• Conduct semi-annual and annual performance appraisals for the department as well as implements development activities for all personnel.
• Manage and implement programs in concert with ARI’s cultural initiatives.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability needed.

• Bachelor’s degree in computer science required. Advanced degree preferred.
• Minimum 10 years in a management or leadership role within a pharmaceutical environment required. This should include experience successfully managing multi-disciplinary teams as well as multiple IT and software implementation projects. Demonstrated aptitude for effective leadership of staff.
• Extensive experience in computer system validation within a GMP-regulated environment.
• Extensive knowledge of US GMP regulations and established expertise in interpreting and application to the business including DSCSA, ICH, 21 CFR Part 11 compliance and data integrity requirements.
• Direct experience taking part and supporting regulatory inspections and submissions.
• Incumbent must be able to think analytically and provide prompt resolution to