Responsibilities
- Lead, coach, and develop QC managers, supervisors, and laboratory teams across chemical, physical, and microbiological testing functions.
- Ensure laboratory operations comply with SOPs, GLP, GDP, cGMP, data integrity, and internal quality standards.
- Oversee quality systems, audits, compliance programs, and implementation of new regulatory requirements.
- Manage laboratory operations to ensure safe, reliable, and efficient testing support for manufacturing activities.
- Develop and implement QC strategies, monitoring systems, and performance management processes.
- Review and approve SOPs, quality documentation, and periodic review activities.
- Manage QC personnel, laboratory projects, and quality risk assessments.
- Plan and track laboratory objectives, timelines, resources, and priorities.
- Prepare business cases for laboratory equipment, staffing, and service improvements.
- Ensure timely testing and analysis of raw materials, intermediates, water samples, and finished products according to regulatory and quality requirements.
- Manage laboratory budgets and capital expenditure planning.
- Promote and maintain a safe laboratory environment and support EHS investigations when required.
- Ensure laboratory instruments and equipment are qualified, maintained, and operating effectively.
- Collaborate with cross-functional teams including Production, Supply Chain, Procurement, Warehouse, and Process Development.
- Oversee analytical method transfers, method validation, verification, and development for new and existing products.
- Support implementation of site and corporate projects within scope and budget.
- Drive continuous improvement initiatives using root cause analysis, Right First Time (RFT), Lean, Six Sigma, and Statistical Process Control (SPC) methodologies.
- Ensure stability programs and testing data are completed and reported on time for product reviews and regulatory submissions.
- Ensure laboratory automation systems remain functional and efficient.
- Lead team performance management, coaching, employee engagement, and compliance culture initiatives.
- Support data integrity practices and ensure adherence to GMP requirements.
- Act as a role model for quality, compliance, and operational excellence.
Requirements
- Min Bachelor or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy, Pharmaceutical Sciences or Microbiology or a related science.
- Min 8-10 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable.
- Minimum 5 years in a leadership/supervisory position of professional staff previously, or demonstrated capability to successfully lead large teams.
- Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.
- Strong leadership, people management, and stakeholder engagement skills.
- Experience interacting with senior management, auditors, and regulatory agencies.
- Strong technical knowledge of analytical chemistry, laboratory instrumentation, analytical method validation, and laboratory automation.
- In-depth understanding of cGMP, GLP, GDP, and data integrity requirements.
- Experience with laboratory systems such as LIMS, HPLC, GC, and chromatography software.
- Knowledge of Lean, Six Sigma, standard work practices, and continuous improvement methodologies.
All qualified applicants, please send in your resume to:
[Confidential Information]
Tricia Celestine Goh (R1981653)
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