Purpose

The IT Validation Manager is responsible for providing validation services in a GxP environment. This role will lead a team with accountability for validation of regulated IT systems, ensures planning and execution of validation tasks and providing strategic direction to ensure robust validation services.

Leads and drives compliance and validation activities across multiple projects or stakeholder areas. Supports resource planning and allocation across multiple areas for IT Compliance validation activities.

The role will involve partnerships with peers, stakeholders, and business, provides senior-level consultation and direction to functional areas for GxP system validation policy, process, and procedures.

The position ensures that defined system validation practices and procedures are being followed including the interpretation and communication of GxP regulatory compliance regulations.

The Validation Manager will have the responsibility to identify, propose, initiate, and lead significant improvement programs related to IT Validation Compliance policy, processes, and procedures including CSA initiatives and testing automation.

Responsibilities

• Lead harmonization of validation services in a GxP environment. Drive alignment for GxP compliance with applicable regulatory and Global policies and procedures, ensuring validation documentation is in accordance with cGMP.

• Ensure delivery and support of validation projects, provide guidance during review and approval of IT system documentation, leverage risk-based approach and automated testing tools where possible.

• Provide support of change control process to ensure execution is compliant with internal policies and procedures for validation aspects.

• Build and sustain relationships with system stakeholders, business stakeholders, and teams responsible for providing validation services support, including Managed Service Provider resources.

• Drive and promote the available validation services, engaging and building partnerships to enable strong relationships.

• Monitor and oversee validation projects to ensure project timelines and enable fulfillment of validation projects by providing complete, and accurate project validation documentation. Provide daily oversight to Managed Service Provider’s fulfillment of validation services, providing feedback and driving to Right First Time.

• Finance management of projects and validation contract services.

• Implement process improvements for stakeholders; document lessons learned, leveraging learnings to influence improvements across teams and address/resolve any actions identified.

• Promote continuous improvement and efficiency within process design and delivery. Drive process improvements, identifying opportunities to simplify and streamline solutions while ensuring organization remains compliant.

• Develop and publish metrics, focused on identifying improvement opportunities to reduce compliance risk.

Qualifications

Bachelor's Degree with 8 years of experience; Master’s degree with 6 years’ experience.

8 years of experience in a formal system development lifecycle with at least 5 years in a GxP software environment.

3 years of experience leading teams.

3-5 years’ experience in a regulated system development / validation environment, leading software validation efforts or providing software quality assurance support and managing teams.

Experience in a quality systems environment, preferably manufacturing/quality experience with a good understanding and application of GMP and regulatory requirements including knowledge of applicable regulations and standards that affect IT systems.

Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with IT management and staff.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.