Associate Director, QC Biological (Microbiology Focused

Position Overview

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. The leader will be responsible for hiring plans, budget development, strategic planning, and driving results. This role plans, schedules, and oversees multiple QC laboratories in order to drive compliance goals, schedule adherence, profit plans, and strategy objectives of the company and the department.

The Associate Director, QC Biological identifies operational needs for special projects (new product sub‑team, capital projects, etc.) ensuring site/divisional linkage is achieved. The Associate Director, QC Biological will identify and address short‑term, intermediate, and long‑term issues in a satisfactory manner, and appropriately resolve conflict and prioritize work as necessary, managing through levels including managers, supervisors, and individual contributors.

• Translate company goals into relevant department objectives, focused on assuring compliance, supply, profit plan, strategy, and people/culture objectives are appropriately implemented
• Provide logistical and strategic support for achieving department objectives
• Represent the department for manufacturing, customer, and COE related activities as they relate to resource management
• Assure the laboratory is capable of delivering proposed or scoped customer requirements
• Assure adherence to headcount and budget plans
• Initiate and drive implementation of technology and projects aimed at cost reduction, efficiency improvements, minimization of downtime, and quality/safety enhancement. Foster an environment for continuous improvement
• Maintain state of inspectional readiness for the department
• Assure appropriate training requirements are established and that staff maintain currency to the curricula
• Assure team delivers on‑time results with right first‑time quality
• Make decisions on equipment selection, qualification, and maintenance
• Assure transferred methods align with department analytical platforms
• Provide training and assurance that transferred methods are fit for purpose and QC personnel are trained to perform the methods consistently
• Assure Quality System requirements are delivered according to determined schedules
• Foster a safe working environment through appropriate training and engagement of QC staff
• Assure policies, practices, and standard work are consistent across the department
• Conduct group communication meetings to facilitate project efficiency and/or distribute information
• Develop and manage group against KPIs to assure alignment with objectives and manage to target
• Participate in the development and management of capital and expense budget
• Participate in and develop employee development plans to assure continuity to mid‑ and long‑term succession plans
• Manage and develop direct and indirect reports
• Administer company policies such as time off, shift work, and inclement weather that directly impact employees
• Complete required administrative tasks (e.g., timecard approvals, time off approvals, expense reports, etc.)
• Coach and guide direct reports to foster professional development
• Participate in the recruitment process and retention strategies to attract and retain talent, as needed
• Address performance gaps, employee questions and concerns, and partner with HR as needed for resolution
• Perform other duties, as assigned

• 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

• 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…