Location : Tuas Biomedical Park (Company shuttle bus provided islandwide)
Responsibilities:
- Manage all operational activities for Quality Control (QC) Microbiology and Environmental Monitoring (EM) to support raw material, inprocess, drug substance, and drug product lot release, stability testing, and EM for site projects.
- Oversee microbiology testing and method qualification, including bioburden, CCIT, endotoxin, and sterility testing for raw materials, inprocess materials, and final products.
- Perform technical review of pharmacopeial requirements (USP/EP/JP/ChP) to ensure test methods and procedures meet current standards and regulatory expectations.
- Ensure all microbiology and EM operations comply with current GMP and regulatory authority requirements.
- Establish, maintain, and optimize the site environmental monitoring strategy, including routine monitoring, microbial identification, and trend analysis.
- Perform or participate in quality risk assessments related to microbiological control and environmental monitoring.
- Lead investigations of microbiological issues impacting release testing, stability testing, utilities, facilities, and EM activities.
- Conduct root cause analysis and define appropriate corrective and preventive actions (CAPAs) to address deviations and excursions and prevent recurrence.
- Manage deviations, change controls, and CAPAs within the QC Microbiology and EM scope.
- Support and participate in client, internal, and regulatory audits and inspections.
- Initiate, lead, and support continuous improvement initiatives within the QC Microbiology/EM team, including integration of company-wide programs such as the Wuxi Business System (WBS).
- Develop and implement training programs for QC Microbiology and EM personnel, ensuring compliance with cGMP, microbiology practices, SOPs, data integrity, intellectual property, GMP, GDP, and EHS requirements.
- Ensure staff are adequately trained, qualified, and compliant with all applicable quality and safety requirements.
- Conduct annual performance evaluations and manage the performance and development of direct reports.
- Lead talent recruitment, development, and succession planning, fostering a culture of continuous learning and operational excellence.
- Promote and participate in cross-site collaboration among Microbiology teams, including COE meetings, EM strategy harmonization, and method optimization initiatives.
- Establish GMP cellbanking specifications and issue Certificates of Analysis (COAs).
- Participate in crossfunctional and sitelevel meetings to align on strategies, decisions, and initiatives.
- Perform other duties as assigned by the QC Head.
Education & Experience
- Bachelor's degree in Chemistry, Microbiology, Biochemistry, or a related scientific discipline; an advanced degree is an advantage.
- 8- 12 years and above of relevant experience in Quality Control or a related pharmaceutical/biologics environment, with depth of expertise appropriate to the role and level of responsibility.
- Proven people management experience, including leading teams, performance management, and capability development.
Technical & Professional Requirements
- Strong knowledge of microbial contamination control and microbiological testing methods, with demonstrated ability to apply this expertise in providing QC leadership across Microbiology and Environmental Monitoring functions.
- Subject matter expertise and handson experience in pharmaceutical microbial control, including routine testing, investigations, and compliance activities.
- Solid understanding of environmental control regulations and industry guidelines, with indepth knowledge of current Good Manufacturing Practices (cGMP).
- Experience in validation, qualification, and execution of microbiological test methods, microbial identification techniques, and evaluation of new technologies or alternative methods.
- Demonstrated experience in leading and executing investigations using root cause analysis tools and methodologies.
- Working knowledge of Quality Systems, including document management systems, learning management systems, change control, deviation management, and CAPA programs.
Leadership & Personal Attributes
- Ability to transition effectively between strategic planning and handson execution while managing multiple priorities to meet departmental and site objectives.
