Laurence Grand

WORK HISTORY

EDUCATION

SKILLS

ABOUT LAURENCE GRAND

SUMMARYProfessional with over twenty-five years of experience in the pharmaceutical/chemistry industry, including personnel management.Experience with multiple dosage forms: oral solid, topical, and aseptic as QC/QA Manager/Director.Successfully managed QC, QA, and AD functions, based upon multiple regulatory requirements of FDA, EMA, ISO, ICH and GxP.Developed and managed GxP quality systems.Demonstrated strong managerial experience in analytical leadership, development of guided strategies, and successful business solutions. Challenged existing organization processes and provided competitive alternatives resulting in increases of laboratory performance as measured in throughput and reduced nonconformances. Excellent interpersonal skills working as a team player and building solid cross function relationships with the ability to work individually. Negotiated successful outcomes with external and internal stakeholders. Thrives in high pressure complex situation requiring complex solutions resulting in risk reduction. SKILLS• Management • Project Management• Training • Conflict ResolutionQUALITY• Development and management GxP systems• Technical Writing including Validation documents, SOPs, Batch Records, CMC sections for IND/NDA/DMF submissions.• GMP Compliance and Due Diligence assessments.• Remediation• Experience in inspections, including GMP inspections by MHRA, US FDA, ANVISA, EMA, SWISSMEDIC• Experience in auditing companies, Risk assessment, Deviation, CAPA, OOS/OOTEXPERTISE• Analytical Development & Validation, Transfer, Stability, Cleaning Validation• Equipment: HPLC, GC, IR, UV-Vis, KF, GC/MS, HPLC/MS, Dissolution, ICP, and AA,• DATA Integrity SME• Equipment qualification IQ/OQ/PQ• Technical TransferLANGAGE• French (native language)• English (fluent)• German and Italian (basic)