Director/Associate Director (Micro/EM)

Responsibilities

1. Manage all operational aspects of the Quality Control Microbiology and Environment Monitoring functions in support of raw material, in-process, drug substance and drug product lot release, stability testing, and environmental monitoring (EM) for site's projects.

2. Oversee microbiology related testing and method qualification, including bioburden, CCIT, endotoxin and sterility testing of raw material, in-process and final products. Perform technical review of USP/EP/JP/CHP to ensure methodology and procedures are compliant with the current standards. Ensure in-house operations are complying towards latest GMP and regulatory authorities requirements.

3. Oversee the set-up of environmental monitoring strategy, conduct routine monitoring and perform trend analysis, Isolates identification. Perform or participate in quality risk assessment when necessary.

4. Oversee the investigation of microbiological quality problems in release and stability testing, utilities and facilities, and EM to analyze and propose appropriate CAPAs to resolve deviations/excursions and to prevent recurrence.

5. Manage deviation, change control and CAPA, participate in client or regulatory audit inspections.

6. Initiate, lead, support and oversee continuous improvement initiatives for QC Microbiology/EM team. This includes on-going company's initiatives such as the integration of WBS (Wuxi Business System) into routine operations.

7. Responsible for developing Quality Control Microbiology and Environment Monitoring teams training program. Ensure all staff receive necessary training in cGMP training, Microbiology and SOPs. Ensure staff are following company IP, data integrity, GMP, GDP and EHS requirements.

8. Responsible for staff annual performance appraisal and managing performances of direct QC reports.

9. Responsible for talent recruiting, development and fostering a continuous learning and improvement environment.

10. Promote and participate in collaborative work among cross-sites Microbiology groups such as COE meeting, optimization/harmonization of EM strategies, procedures and other method optimization initiatives.

11. Responsible for GMP cell-banking SPEC establishment and issue COA

12. Participate in site's cross departmental meetings and ad hoc meetings to initiate or align decisions or strategies when necessary.

13. Other tasks assigned by QC head.

Qualifications

1. Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.

2. 12+ years of relevant experience or equivalent for Bachelors

3. 8+ years for Master's in the Quality Control or related field or equivalent experience.

4. 4+ years of Management experience required.

Other requirements (e.g.: working time, special skills)

1. Knowledge of microbial contamination control, microbiological methods and demonstrated capability in using that knowledge to provide QC leadership to all aspect of microbiology and environmental monitoring.

2. Subject matter expertise (SME) and hands-on proficiency with all aspects of pharmaceutical microbial control.

3. Experience and understanding of environmental control regulations and guidelines with in-depth understanding of cGMP.

4. Experience in validating and executing microbiological testing methods, identification methods, and evaluating new technology or methods.

5. Experience with application of root cause analysis tools for investigation execution.

6. Experience with Quality Systems (e.g. Document/Quality/Learning management system, Change Control, Deviations, and CAPA programs).

7. Able to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.

8. Self-motivated and organized.

9. Excellent communication skills (both verbal and written) and interpersonal skills are required.