Corinne G.

About Corinne G.

I’m a Quality Assurance & Regulatory Affairs professional with 8+ years of experience ensuring GMP, GCP, and ICH compliance across biologics, drug substance, and drug product environments. I specialize in bridging QA and Regulatory functions, managing change controls, CAPAs, CMC documentation, supplier audits, and inspection readiness with precision and collaboration.My background includes hands-on experience with FDA, EMA, and ICH guidelines, oversight of global CMOs, and cross-functional coordination for IND, BLA, and NDA submissions. I’ve supported regulatory documentation review, quality events, and continuous improvement initiatives that strengthen compliance systems and accelerate time-to-release.Tools I’m fluent in: Veeva Vault, TrackWise, MasterControl, Smartsheet, SAP, and LIMS. I’m open to remote or hybrid opportunities in Quality Assurance or Regulatory Affairs where I can leverage my QA foundation to support CMC strategy, supplier oversight, and regulatory readiness for Supplier Audits & CMO Oversight Inspection Readiness Cross-Functional Biotech & Pharma organizations.**Core Competencies:** GMP & GCP Compliance Regulatory Submissions (IND, BLA, NDA) Change Control & Deviations Supplier Audits & CMO Oversight Audit Readiness & CAPA Management Cross-Functional Collaboration Smartsheet, TrackWise, Veeva, SAP and more

Experience

1. Manager, Quality Assurance Supplier Qualification

   BioNTech SE

   May 2023 — Present

   As part of the Global Supplier Qualification team, I support supplier and vendor qualification and management activities across clinical and commercial programs in biopharmaceuticals and gene therapy. My role bridges compliance, audit oversight, and supplier risk management to ensure adherence to FDA, EMA, and ICH regulations.Key Responsibilities & Achievements:Conduct and support supplier and service provider qualifications for GMP and GxP operations.Coordinate, follow up, and close out supplier audits, partnering with lead auditors and external experts to ensure quality expectations are met.Prepare auditee documentation, assess qualification questionnaires, and review supporting quality records for supplier approval.Contribute to the annual audit plan, supplier evaluation, and maintenance of the global audit list.Supervise supplier risk assessments and ensure mitigation plans are effectively implemented.Support global harmonization of supplier qualification processes across all BioNTech sites.Participate in the migration of supplier qualification documentation to an electronic quality management system (eQMS).Collaborate across US and EU teams to maintain alignment with international GMP and GDP standards.Tools & Systems:Visio, Veeva, ERP, eQMS, SharePoint, Microsoft Teams, Excel, and ProjectRegulatory Knowledge:21 CFR Part 211, EU-GMP, EudraLex Vol. 4, ICH Q7–Q10, GDP, USP/EP compendia, ISO standards#SupplierQuality #Audits #GMPCompliance #QualityAssurance #Biopharma #GeneTherapy #eQMS #Veeva

Education

• University of Maryland Global Campus

  Bachelor of Applied Science - BASc, Biotechnology

• Montgomery College

  Associate of Science - AS, Biotechnology