Job Description

The Validation Manager will be responsible to provide quality support and oversight for GMP software validation activities and to maintain data integrity standards as per 21CFR Parts 210, 211, 11, and ensuring compliance with relevant regulatory requirements and industry standards/best practices.

Essential Duties and Responsibilities:

The responsibilities for Manager may include but are not limited to the following activities: Provide Quality oversight of Computer System Validation, Computer Software Assurance activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of systems.

Execute and manage risk assessment, planning, and execution/mitigation activities to ensure computerized systems used to support operations are maintained in a qualified state throughout their lifecycles.

Participate in project teams to provide guidance and approval of project Validation documentation and relevant Change Controls.

Manage the software-based data integrity program, including the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations etc.).

Author and/or review and approve relevant GMP software validation documentation.

Deliver training on validation and data integrity principles/requirements to foster employee awareness and accountability.

Create and/or revise SOPs supporting validation and data integrity activities.

Stay technologically current, investigate new technology and instrumentation; act as a technical resource for internal problems and projects; stay current with regulatory requirements; interpret regulations and coordinate implementation of new internal programs and procedures.

Development of budget, monitor expenses, look for cost-saving applications; provide routine departmental business review updates to executive management.