Associate Director, QC Biological

About the role

The Associate Director, QC Biological is responsible for managing multiple labs within the Quality Control department including QC Microbiology. The individual acts 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 compliance, supply, profit plan, strategy, and people/culture objectives are appropriately implemented
• Provides logistical and strategic support for achieving department objectives
• Represents department for manufacturing, customer, and COE related activities as they relate to resource management
• Affirms laboratory capability to deliver 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 curriculum
• 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
• Adds to 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

Physical & Work Environment Requirements

• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability to sit for prolonged periods of time up to 240 minutes
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
• Works in warm/cold environments
• Works in heights greater than 4 feet