Job Title: Associate Director, QC Microbiology


1) Purpose: Based on the QC overall strategy, accountable for supervising and managing routine microbiological testing and environmental monitoring for manufacturing operations, assuring network-wide harmonization of control systems by proactive lifecycle management. Drive analytical innovation including new technologies; provide QC-related solutions to QC network to drive continuous improvement, standardization, automation, productivity and agility.

2) Key Responsibilities/Tasks:
· Lead and manage QC microbiology lab team to effectively execute all routine due tasks in compliance with internal procedures and external requirements and regulations.
· Hire right staff to build up a competent team who can accomplish the tasks in pace with local manufacturing activities.
· Work with project leads and clients by providing strategic direction and leadership of activities for supporting method transfer and microbial contamination control strategies.
· Support the QC network teams to manage, align and drive continuous improvement of microbiology methods across WuXi QC sites
· Provide technical input in technical activities related to microbiological applications including analytical control system development, scientific reviews, validation, comparability assessments, and lifecycle management.
· Build internal knowledge and capabilities at sites on new methods. Establish standards, business processes, tools and training for QC Microbiology across the QC network. Proactively share microbiology expertise with other functional groups to generate alignment and improvement opportunities.
· Provide technical subject matter expertise to the network including method validations, specifications, and troubleshooting issues including Annual Product Quality Reviews, discrepancies/investigations, CAPAs, changes and Health Authority inspections.
· Represent QC Microbiology as the primary technical expert at Quality Review Boards and other decision-making forums, technical development teams and technical product teams, and for quality system documents to address relevant topics related to microbiology.
· Support regulatory filings and health authority information requests related to microbiology.
· Actively engage in external influencing and industry best practice discussions to advance strategic priorities.

Requirements:
1 Bachelor degree and above in general Biology, Microbiology, Clinical Microbiology, Food Microbiology or a related field. 8 years (for Bachelor), 5 years (for Master) or 2 years (for doctor) hands-on experience with QC microbiology in pharmaceutical industry is minimum.
2 Broad knowledge in GMP compliance, QC microbiology and microbial contamination control system.
3 Experience of team management
4 Highly motivated to embrace new technologies and tools.
5 Good communication skills and team work spirits.
6 Fluent in reading, writing and speaking English.
7 Regulatory audit experence is perfered
8 Biologics manufacture facility and utility supporting experience is perfered.