Director, Project Management & GxP Execution

Nature and Scope

The Director of GXP Project Management & Execution will lead a team to oversee project management and execution activities related but not limited to GXP and GMP software implementation projects across American Regent. The incumbent is responsible to ensure the GxP 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 timely completion of projects through proper allocation of workload and resources, appropriate prioritization of tasks, and timely 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 objectives. Responsible for preparing reports to present to management detailing the activities and progress of the department.

The incumbent will also build and maintain 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 and to perform and /or appropriately delegate activities required for successful project management and execution 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 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 GxP and DI.
• Provides constant support to the organization through, planning, and timely 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 GxP and DI practices follow current regulations and industry standards.
• Prepare for and support regulatory inspections and audits.
• Conduct risk assessments and ensure appropriate controls are implemented.
• Establishes weekly, monthly, quarterly, and annual performance reports on projects as required 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.
• Assures adequate staffing to support all projects.

• Analyzes 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 additional responsibilities to personnel to complete projects on schedule.

• Assists in the training of new and existing staff to ensure that they are well versed with the procedures required for projects.
• Conducts semi-annual and annual performance appraisals for the department as well as implements development activities for all personnel.
• Responsible for managing and implementation of 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 required.

• Bachelor's degree in a relevant field (e.g., Computer Science), required. Advanced degree preferred.
• Minimum 10 years in a supervisory or leadership role with appropriate management level experience within a pharmaceutical environment. This should include experience successfully managing multi-disciplinary teams as well as multiple projects. Demonstrated aptitude for effective leadership of staff.
• Extensive knowledge of US GMP regulations and established expertise in interpreting and application to the business including DSCSA and ICH requirements.
• Direct experience participating and supporting regulatory inspections and submissions.
• Problem solving and analytical skills: Incumbent must be able to think analytically and provide timely resolution to all issues/challenges that may occur during a project.
• Skilled in planning, budgeting, and financial analysis
• Experience with Microsoft Office, and electronic quality systems (Trackwise, Veeva Vault, LIMS, SmartSheet, etc.)
• Communication skills: Must be an active listener and speaker who can easily manage the flow of information and instructions throughout projects.
• Possess exceptional organizational, interpersonal, and communication (oral and written) skills.
• Primarily office-based with occasional travel to manufacturing sites and external partners as required.
• Participation in regulatory inspections and audits may be required.
• This role can be Hybrid depending on experience.

Expected Salary Range:

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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