Associate Director, QC Technical Services & Project Management - LSA (Biotech)
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.
