Associate Director, QC Technical Services
1 day ago
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.
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Portsmouth, United States Lonza America, Inc. Full timeToday, Lonza is one of the worlds 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 Project Management, Director, Technical, QC, Associate, Management, Business Services, Manufacturing
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