"Alerted.org

Job Description

Insight Global is seeking an IT Compliance Lead local to their Richmond, VA, or Raleigh, NC, locations. This lead is highly skilled in Computer Systems Validation (CSV) with strong GxP experience and responsible for the development, maintenance, and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies. They will work closely with Business Units, IT teams, Quality, and Regulatory functions to define computer system validation requirements and ensure IT project delivery, application management and change management solutions are managed in compliance with Pharmaceutical and Manufacturing industry regulations and department procedures.

This lead must have 7+ years' experience in: pharmaceutical business processes with manufacturing and IT solutions, working with pharmaceutical industry regulations and guidelines (FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP), a Computer Systems Validation (CSV) role, inspecting GxP's by regulating authorities, working with IT validation document repository, electronic signature solutions, and IT application development.

Day to day responsibilities include: determining strategy for IT compliance governance, partnering with IT leadership on business initiatives and supporting IT compliance team members to improve technical abilities and career development, maturing IT documentation, reviewing and approving IT governance and procedure documents, providing CSV and system implementation expertise to the Business Units and IT functions, providing oversight by coordinating IT risk reviews with the IT leadership team and stakeholders, and being the IT contact for internal, financial, and ITGC audits. The salary for this role ranges from $130,000-$160,000, based on experience.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

Skills and Requirements

-4 year Bachelor's Degree

7+ years' experience in:

-Pharmaceutical business processes with manufacturing and IT solutions

-Dealing with pharmaceutical industry regulations and guidelines (FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP), ensuring compliance with international pharmaceutical regulations and company policies

-Computer Systems Validation (CSV) role (3+ years of leadership), providing system implementation expertise to Business Units and IT functions

-GxP inspections performed by regulating authorities

-Working with IT validation document repository (ValGenesis)

-Electronic signature solutions (Adobe and DocuSign), IT control management system (AuditBoard), and corporate quality management system (TrackWise and Veeva)

-IT application development, implementation, and support processes (project planning, software lifecycle, writing project deliverables)

-Strong communication and leadership skills to partner with IT leadership on business initiatives and coordinate IT risk reviews with stakeholders

-Reviewing and approving IT governance, procedure documents

-Overseeing and developing key validation deliverables and gaining approvals from the Business Units and IT functions

-Developing and leading training programs to team members on CSV

-IT contact for internal, financial, and ITGC audits; attend vendor audits as CSV and IT Compliance SME; coordinate completion of audit questionnaires by IT vendors

-Customer focused and driven personality null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].