Laboratory equipment qualification and maintenance
The incumbent will lead a team of QC Managers and supervisors to ensure all analytical testing and data review activities comply with regulatory standards
Job Summary
The incumbent will lead a team of QC Managers and supervisors to ensure all analytical testing and data review activities comply with regulatory standards.
Responsibilities include developing integrated quality systems, managing budgets, and ensuring laboratory equipment meets rigorous regulatory qualifications.
The role requires promoting a strong quality culture, utilizing Right First Time methodologies, and driving continuous improvement projects across the site.
Matching Summary
The incumbent will lead a team of QC Managers and supervisors to ensure all analytical testing and data review activities comply with regulatory standards.
Skills & Requirements
Must-have
cGMP GLP GDP compliance knowledge
analytical chemistry and microbiology testing
laboratory equipment qualification and maintenance
team leadership for QC managers and supervisors
data integrity and Good Documentation Practices
budget management and capital expenditure planning
method validation and analytical method transfer
Nice-to-have
Six Sigma and Lean Labs methodologies
Statistical Process Control (SPC) expertise
continuous improvement and problem solving skills
experience with LIMS and Empower software
cross-functional collaboration with production teams
digital technology adoption for efficiency
Key Requirements
Bachelor or Master or Ph.D. in Science or Life Sciences
Minimum 8-10 years technical experience in Quality Control
Minimum 5 years in a leadership or supervisory position
Strong knowledge of analytical method validation and instrumentation
Comprehensive knowledge of cGMPs, GLPs, and data integrity