Renee Brueggeman

Lead Quality Assurance and Regulatory Affairs functions across pharmaceutical and operations divisions. Directed multi-shift QA/QC teams totaling 35+ personnel. Developed and executed quality strategies ensuring alignment with FDA and cGMP. Managed quality oversight for OTC, Supplement, Rx, and Controlled substances launches including validation, change control, and product development. Partnered with executive leadership to standardize quality frameworks across divisions, elevating audit readiness and inspection outcomes. Championed employee training initiatives and succession planning, growing internal talent pipeline. Oversaw complaint investigations, CAPA lifecycle, and deviation management for product lines. Developed department strategy plan.

Managed GMP compliance and quality control functions within Quality Operations environment. Authored SOPs, conducted internal and vendor audits. Initiated and completed CAPA and deviations. Trained and mentored junior QC team members, resulting in a progressive responsibilities and promotions.