Director of Validation

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POST DATE 9/8/2016
END DATE 10/9/2016

Neos Therapeutics Grand Prairie, TX

Grand Prairie, TX
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


Position Summary:

Functional responsibility, leadership and management of the following: process validation, facilities, utilities, and oversight of equipment qualification, computer system validation, and Engineering.

Key Job Functions and Responsibilities:

Plan, organize, and direct the functions of Validation
Create a clear vision to build an organization to support the growing validation needs of the company (both internally and externally)
Create and implement a plan to enhance, optimize and improve systems requiring validation
Develop appropriate metrics to monitor effectiveness and efficiency of the validation program.
Provide subject matter expertise during regulatory and partner inspections
Proactively establish, communicate and lead Validation strategies, needs/requirements and associated action plans (tasks, duration, owners)
Establish effective communication and collaborative relationships with other functional groups and key stakeholders
Participate in multi-departmental meetings and project teams, representing functional groups
Develop, define, and enforce departmental policies and practices for functional groups
Forecast and manage cost center budget and staffing needs (internal and external)
Hire, train, develop, evaluate, discipline, and support managers, supervisors, and employees in functional groups
Evaluate and handle employee performance, productivity and complaints
Train employees in inspection requirements and promote technical development
Responsible for performing secondary activities relating to the handling, processing and analysis of narcotics and other controlled substances, in areas where narcotics and other controlled substances may be present.
Perform other duties as required.