QC Lab Manager (process improment, Change maker)

Key Responsibilities

• Lead and develop QC teams
• Ensure compliance with GLP, GDP, cGMP, and Pfizer Quality Standards (PQS)
• Oversee laboratory operations, including analytical testing and equipment systems
• Manage QC quality systems, audits, and regulatory requirements
• Provide QC expertise to cross-functional teams (Production, Supply Chain, etc.)
• Lead Analytical Method Transfer (AMTE) and method validation activities
• Drive continuous improvement initiatives (RFT, SPC, Lean/Six Sigma)
• Manage laboratory budget and CAPEX planning
• Ensure EHS compliance and a safety culture
• Support regulatory reporting and stability programs
• Act as a leader and role model for compliance and quality culture

Qualifications & Experience

• Degree in Chemistry, Pharmaceutical Sciences, Microbiology, or related field
• 8-10+ years of QC experience in pharmaceutical or related industries
• Minimum 5 years leadership experience managing teams
• Background in:
  • Analytical chemistry and method validation
  • Laboratory systems (LIMS, HPLC, GC, Empower)
  • cGMP, GLP, and data integrity
    

Winnie Chen Hsiu-Wen EA License No.: 02C3423 Personnel Registration No.: R1980765

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