Job Description
Insight Global is seeking an Associate Manager of Quality Compliance who is responsible for overall compliance of Quality systems, Standard Operating Procedures, CFR guidelines, DEA guidelines, DSCSA guidelines, Internal and External audits etc.
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 HR@insightglobal.com.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/.
Required Skills & Experience
- Experience handling Change controls/ Deviations/ Incidents/ CAPA/Risk Assessment/ Product Quality Complaints etc., which includes initiation to closure, effectiveness and trending.
- Understanding of DQRS (Drug Quality Reporting System) cases, coordinating with manufacturing sites for investigation and Regulatory Affairs for arranging more information/ samples from FDA.
- Experience handling Field Alert Reports and Product Recalls
- Experience complying to DSCSA (Drug Supply Chain Security Act)
- Experience handling Internal and External audit
- Experience handling controlled substances
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.