Associate Director, QC Technical Services & Project Management - LSA at Lonza Inc. in Portsmouth, New Hampshire

Job Description:

Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents.

Responsibilites

• 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


• Collaborates 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 Measures appropriate metrics and report them to management.


• Maintains a routine based communication with internal/external supplies and contract testing labs (CTL) for on-going and futural testing.


• Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management.  Sets and delivers on individual and team goals that support the department and site strategy.  Takes personal accountability for both his/her own and the team’s actions.   


• Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA). 


• Prepares project plans, writes status reports, and gives oral presentations to customers and management. 


• Prepares monthly management reports including budget analysis and project updates. 


• Actively monitors spending for area. Predicts and escalates potential spending variances.  Identifies corrective actions for spending variances. 


• Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.


• Performs other duties as assigned.

Requirements

• Bachelor’s Degree is required.


• 5-10 years of experience is required.