• Manager of Quality Systems & OPEX

    Insight Global (Midlothian, VA)


    Job Description

    Insight Global is looking for a Manager of Quality Systems and OPEX to support a pharmaceutical company in the Greater Richmond Region. This role is key in creating strategic plans with cross functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System (PQS). This person will support the review and approval of all GxP IT system change controls and validation documents, manage the product quality complaints process, and support the business by facilitating global Deviation and CAPA management

     

    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 opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their 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 or uniformed service member status, 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 [email protected] 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

     

    - Bachelors Degree in Life Sciences

     

    - 8 years of quality experience, in a regulated industry such as FDA regulated and pharmaceutical

     

    - Experience supporting computer system validation (CSV) activities across an organization

     

    - Has partnered with the commercial side of the business to support system changes and validation needs

     

    - Systems: Veeva or TrackWise