The posting
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical
Responsibilities :
- Provide overall leadership and oversight of the QC Microbiology and Environmental Monitoring (EM) teams.
- Lead QC Microbiology and EM functions covering critical utilities, environmental monitoring programs, and microbiological testing for water, raw materials, in‑process samples, and product release.
- Establish, manage, and continuously improve site environmental monitoring and contamination control programs, including risk assessments, routine testing, data trending, interpretation, and excursion management.
- Lead investigations, change controls, and improvement initiatives related to environmental control and contamination risks, working closely with Manufacturing, Engineering, Validation, and Quality stakeholders.
- Establish and maintain microbiology testing and qualification capabilities; serve as QC SME for microbiological assays, methods, and emerging technologies.
- Provide expert input on data review, investigations, and quality decisions; lead or support client discussions related to microbiology, EM, and quality investigations.
- Supervise, plan, and review daily operations of assigned staff, including work allocation, scheduling, training, performance evaluation, and talent development.
- Ensure laboratory activities and assays are executed in compliance with cGMP, GDP, CFR, PIC/S guidelines, and company SOPs, including critical review and approval of data and reports.
- Author, review, and approve SOPs, validation and qualification documents, specifications, investigations, and quality records; guide teams in deviation, OOS, OOL, and CAPA management.
- Provide operational, technical, and administrative leadership to the Microbiology/EM organization, ensuring effective resource utilization and team performance.
- Collaborate with management to plan and manage manpower, laboratory supplies, and equipment budgets.
- Drive implementation and continuous improvement of QC microbiology and EM processes, focusing on efficiency, compliance, and inspection readiness.
- Ensure effective communication and documentation with internal and external stakeholders, including project teams, clients, and auditors.
- Support additional tasks or strategic initiatives assigned by the QC Head or senior management to advance departmental and site objectives.
Requirement:
- Bachelor’s degree or above in Chemistry, Microbiology, Biochemistry, or a related scientific discipline; an advanced degree is an advantage.
- 6 years and above of relevant experience in Quality Control or a GMP‑regulated environment with proven people management and/or technical leadership experience.
- Strong knowledge of microbial contamination control and microbiological testing, with demonstrated ability to provide quality and technical leadership across microbiology and environmental monitoring functions.
- Recognized subject matter expertise (SME) with hands‑on proficiency in pharmaceutical microbial control, including utilities, cleanroom monitoring, and product testing.
- In‑depth understanding of environmental control regulations, industry guidelines, and current Good Manufacturing Practices (cGMP).
- Strong scientific and technical expertise, with the ability to apply microbiological theory rigorously in laboratory operations, method development, and continuous improvement.
- Experience in validation, qualification, and execution of microbiological test methods, microbial identification, and evaluation or implementation of new technologies.
- Demonstrated experience in leading investigations using structured root cause analysis tools.
- Strong working knowledge of Quality Systems, including document management, learning management systems, change control, deviation management, and CAPA programs.
- Ability to balance strategic planning with hands‑on operational execution while managing multiple priorities to meet department and site objectives.
- Self‑motivated, well‑organized, and capable of working effectively in a dynamic environment.
