Associate Director, QC Biological (Microbiology Focused)

About the role

The Associate Director, QC Biological is responsible for management of multiple labs within the Quality Control department including QC Microbiology. The individuals will act as a representative of QC in cross-functional meetings focusing on both startup activities and routine operations.

Responsibilities

• Translates company goals into relevant department objectives, focused on assuring the compliance, supply, profit plan, strategy and people/culture objectives are appropriately implemented
• Represents department for manufacturing, customer, and COE related activities as they relate to resource management
• Affirms laboratory is capable of delivering to proposed or scoped customer requirements
• Affirms adherence to headcount and budget plans
• Initiates and drives implementation of technology and projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality/safety enhancement
• Fosters an environment for continuous improvement
• Maintains state of inspectional readiness for department
• Affirms appropriate training requirements are established and that the staff maintains currency to the curricula
• Affirms team delivers on-time results with right first-time quality
• Makes decisions on equipment selection, qualification, maintenance
• Affirms transferred methods align with department analytical platforms
• Provides training and assurance that the transferred methods are fit for purpose and QC personnel are trained to perform the methods consistently
• Affirms Quality System requirements are delivered according to determined schedules
• Fosters a safe working environment through appropriate training and engagement of QC staff
• Affirms policies, practices, standard work are consistent across the department
• Counsels and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Performs other duties, as assigned

Requirements

• Bachelor’s degree in Biology, chemistry or related field with 11+ years of relevant experience OR MS degree with 9+ years of relevant experience OR Ph.D. with 7+ years of relevant experience
• 4+ years of people management and leadership experience
• Experience working in a regulated GMP environment
• Experience managing and developing direct reports and teams
• Experience with QC Methods

Preferred Requirements

• 8+ years of experience working in a regulated GMP environment
• Extensive experience with Drug Product production
• Experience working in a contract manufacturing or testing organization
• Experience with statistical experimental design and data analysis with JMP software
• Experience with QC Microbiology methods, Raw Material testing and contamination control