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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QC Lab Manager (process improment, Change maker)