Alyssa Colón, Mba, Rqap-Glp Email & Phone Number

Waltham, Ma, Us

Waltham, Ma, Us

I was handpicked to overhaul the QA department – the largest site, portfolio, and stake for the division. I demonstrated visionary leadership by transforming an underperforming division with high turn-over to one of the most efficient and high-performance units in the company. I collaborated with Site Operations to revitalize department, pinpoint deficiencies, issue corrective action, brainstorm strategic solutions, and implement a sustainable Quality Culture that thrives on continuous process improvements. Furthermore, I defined KPIs and target goals, while motivating staff to leverage daily dashboards, real-time metrics, and the site QMS to track performance. ✓ Led, equipped, and empowered 16 direct reports and 410+ cross-functional personnel. ✓ Achieved 90% site training compliance, meeting corporate benchmarks. ✓ Bolstered Customer Complaint TAT by 25% while driving down overall complaints by 30%. ✓ Substantially slashed customer and regulatory inspection observations by 46%.

At Glenmark, I spearheaded the Quality Management System life cycle in accordance to DEA, FDA, and Health Canada cGMP regulations. I provided oversight of the CMO Vendor Management program, reporting, change control management, product inspection and receipt, and the US training program. ✓ Directed, developed, and coached 4 Quality Associates. Promoted professional development, engagement, workflow productivity, and retention initiatives in keeping with company priorities, policies, and performance. ✓ Designed the Quality System infrastructure for a cGMP Canada Site in less than 2 weeks that successfully passed Canadian Health Authority inspections with a perfect observation score. ✓ Validated DSCSA-related mandatory systems to track/trace internal manufacturing sites and external partners.✓ Designated leader of all quality functions of External Suppliers, including method development/transfer, analytical testing and qualification, product development phases, product launch, and North American distribution. ✓ Distinguished recipient of 2 Recognition Awards within 1 year. Nominated for the Chairman’s Excellence Award.

In this role, I was a dynamic leader of QA auditing, study inspections, compliance adherence, and infrastructure support. I assessed internal/external providers in accordance to streamline regulatory compliance of all laboratory studies. I also ensured equipment and computer system validation in alignment with FDA GLP regulations, OECD guidelines, and company protocols. ✓ Conceptualized, developed, and deployed the corporate QMS (QAADTM, Master Control Product). Designated Department System Administrator and Super-User that authored the User Manual and training modules. ✓ Primary Inspector for Bioanalytical, Product Stability, Analytical, and GMP manufacturing for clinical supplies (Liquid, Sterile, OSD) and GLP/GCO studies. ✓ Retained as the last auditor to execute all FDA-related activities, including 6 audits and site de-commissioning.✓ Trusted advisor on issue identification, risk mitigation, and process improvement implementation. ✓ Recognized by senior management as an emerging leader within the organization. ✓ Instrumental Quality Partner that onboarded 3 new auditors and facilitated continuous training to 50+ staff.

Master Of Business Administration (Mba), Management

Bachelor Of Arts (B.A.), Biology, Minor In Psychology