The Senior Manager of Inspection will be responsible for the Inspection Operations assuring that the production demand is met in a compliant and safe manner by leading a team of direct and indirect resources while maintaining the operations running in a cost-effective manner within the department's budget.
How you will contribute:
- Responsible for meeting production plan & delivering high quality products to customers in a timely fashion and cost-efficient manner.
- Supervise the daily manufacturing operations for their respective shift.
- Emphasize training and implement control systems on the shift to eliminate product discrepancies.
- Lead and support manufacturing event investigations from initiation to closure in a timely manner to assure compliance with plan. Serve as Manufacturing main point of contact / SME for product impact decisions as appropriate.
- Drive and ensure the right KPIs are implemented and tracked on a regular basis for their shift and cell responsibility.
- Lead by example and maintain production floor presence and focus. Mentor junior level personnel on projects and activities.
- Coordinate necessary manufacturing resources and rally support groups to resolve production-related issues.
- Rapid and relentless approach to address production-related issues by providing sustainable long-term solutions.
- Conduct impartial assessment of shift performance - main priority is overall performance of applicable business unit.
- Constant calibration with other managers focusing on technical background of issue as well as consequences considered when making decisions.
- Commit to employee feedback and developmental processes.
- Manage shift/team, investigate and resolve disciplinary issues.
- Support and emphasize the Safety and Quality commitments of the department.
- Identify/prioritize/provide resources to assist the department director to meet the annual operating plan and budgetary commitments.
- Responsible for driving operational excellence and flawless execution in day-to-day operation of the plant through Visual Management processes.
- Responsible for preparing the department budget and operating within this budget.
Requirements:
- Typically requires bachelor's degree, preferably in science, engineering or other related technical field. 7+ years of related experience with 2+ years in a management role.
- Advanced management and leadership skills. Must have a demonstrated track record of successfully executing within manufacturing environment supporting manufacturing/production issues, in a FDA-regulated manufacturing environment.
- Experience with implementation and driving accountability through visual management
- Possess knowledge of core principles in various manufacturing disciplines (i.e., cell culture / fractionation / purification / aseptic filling / inspection/packaging / cGMP facility design), support systems (WFI / RO / clean steam / compressed gases / HVAC) and facility design.
- Excellent organizational, verbal and written communication skills; able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
- Ability to effectively lead manufacturing production floor and drive results. Direct experience with manufacturing operations and biotechnology processes is strongly preferred.
- Provide a positive and equitable working environment.
- Self-driven individual that requires minimal supervision.
- Ability to solve routine and challenging manufacturing problems without assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
- The person should be able make decisions on the operational processes when unplanned events arise. Should be able to analyze complex problems or situations and provide path forward.
- Contacts to interact with but not limited to are: Quality, Engineering, Manufacturing Science, Supply Chain and Manufacturing. In addition maintain communications with Vendors and Consultants