Associate Director, QC Technical Services & Project Management - LSA

Lonza - Portsmouth, NH

Full-time

Portsmouth, NH

Professional, Scientific, and Technical Services

About the position

The position involves project management within the Quality Control (QC) Laboratory at Lonza, focusing on ensuring compliance with regulatory requirements and internal policies. The role requires collaboration with various departments to create achievable work schedules, manage project timelines, and mentor staff while maintaining effective communication with internal and external stakeholders.

Responsibilities

• Perform project management, identifying QC responsibilities, work to be performed and timelines pertaining to area of responsibility.
• Act as validation SME to complete review/approval of project validation deliverables related to LIMS, Empower, iLAB or other GMP Quality systems utilized within the QC Laboratory.
• Understand Regulatory requirements and Lonza policies pertaining to the area of responsibility.
• Ensure applicable QC policies or procedures are appropriate and established and/or revised as necessary.
• Collaborate with QC Operation, Engineering, CSV, tech transfer, QA, and/or customers to create an achievable work schedule and to ensure agreed upon timelines are met.
• Measure appropriate metrics and report them to management.
• Maintain routine communication with internal/external suppliers and contract testing labs (CTL) for ongoing and future testing.
• Lead, mentor, and coach staff through routine one-on-one meetings, team meetings, and effective performance management.
• Set and deliver on individual and team goals that support the department and site strategy.
• Take personal accountability for both his/her own and the team's actions.
• Prepare responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
• Prepare project plans, write status reports, and give oral presentations to customers and management.
• Prepare monthly management reports including budget analysis and project updates.
• Actively monitor spending for area and predict and escalate potential spending variances.
• Identify corrective actions for spending variances.
• Develop and monitor team performance measures to understand effectiveness, efficiency, and quality of group performance.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree is required.
• 5-10 years of experience is required.