QC Associate Director: Specialist in GMP Lab Operations & Digital Transformation

Executive Summary:

A results-oriented Biotechnology Quality Leader with an MBA and over 12 years of progressive experience in GMP-regulated environments. This candidate excels in leading QC Analytical, Stability, and Raw Materials teams. They have a documented history of managing multi-million dollar budgets ($8M+) and supporting global pharmaceutical supply chains through advanced automation (LIMS/SAP).

Core Technical & Strategic Competencies:

• Regulatory Compliance: Expert-level knowledge of FDA, EMA, and ICH guidelines; proven success in lead roles during regulatory inspections and client audits.

• Laboratory Management: Extensive experience in Method Validation, Method Transfer, and the consolidation of centralized laboratory facilities.

• Financial Oversight: Expert in overhead budget restructuring, ERP inventory optimization, and eliminating absorbed expenses via accurate passthrough billing.

• Systems Expertise: Advanced proficiency in SAP, StarLIMS, GLIMS, ELogs, and 21 CFR Part 11 compliance.

• Operational Excellence: Lean/5S practitioner focused on improving instrument uptime (20%+ increase) and reducing manual errors through digitalization.

  
  

Key Achievements:

• Directed QC operations for major global pharmaceutical manufacturers (including high-volume sterile products).

• Led Cross-functional harmonization initiatives across international sites

  
  

Target Roles: Director of Quality Control, Head of Quality Operations, Site Quality Lead.