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Job Description
Primary Responsibilities
- Utilize a high degree of independent judgment and decision-making to direct quality personnel to ensure manufacturing schedules and customer supply requirements are achieved
- Management of qualifications, re-qualifications, routine monitoring and per-process monitoring of the facilities, utilities, and personnel, as required.
- Ensure all actions are performed per the required schedule and/or business need
- Manage the ongoing trending program for Utility Systems and Classified Areas including evaluating data for adverse trends
- Providing summaries of test results to appropriate personnel as needed
- Development and management of the Risk-Based Incursion Process
- Management of Out of Specification results and required actions by Operations and Quality
- Management for submission of samples in the Global Laboratory Information Management System (GLIMS)
- Compiles and approves Environmental and Utility Annual Review
- Provides direct oversight for the Process Simulation program to include at a minimum program definition, protocol development, monitoring of execution and final report closure
- Develops, edits, writes, reviews and approves departmental SOPs and investigations
- Ensures that all SOPs and documentation associated with these programs are maintained and adhered to
- Manage adherence to departmental Quality metrics
- Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT management processes
- Performs other duties as assigned
- People Management / Leadership
- Applies management skills to align staff activities with department objectives
- Provide leadership to the Quality team including coaching, development, and performance management
- Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations within the team and site
- Provide mentorship and training to team and peers
- Actively participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables
- Adapts and implements departmental plans and priorities to address local business, service and operational challenges. Supports the achievement of plant objectives (e.g., metrics, productivity)
- Manages area in accordance with company policy and applicable government regulations.
- Makes provisions to assure the job responsibilities of the area are conducted in a timely and reliable manner to meet production demands. Accountable for the performance of workgroup
- Responsible for the necessary personnel and equipment resources to ensure that customer expectations are met or exceeded. Forecasts resource needs and aligns resources with business unit needs
- Responsible for knowledge of current Good Manufacturing Practice (cGMP) and safety requirements, as well as the transfer of that knowledge to employees
- Routinely makes decisions that impact the unit’s ability to meet performance objectives using cGMP and safety knowledge as a guide
- Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence
- Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes. Reports to the Associate Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only
- Responsible for administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration
- The incumbent assures that all subordinates are being developed to provide a resource for future growth and opportunities within the site or company
- Applies leadership principles to all actions
- Performs the duties and responsibilities of the Associate Director in his/her absence, as required
Cost
- Ensure that activities are carried out in accordance with departmental budget
- Recognize and implement opportunities for efficiency and financial savings
- Provides shop floor related input to departmental budget and recommends continuous improvement opportunities and capital projects for the IPT
- Continuous Improvement
- Partner with Technology, Op