Job Summary
Autoimmunity Sr. Managers are responsible for managing the overall operations, business results and performance for their assigned department(s). Responsible for department functional plans, determining current and future position profiles and staffing needs, proposing and managing department budgets, performance metrics and reporting, analyzing operations to identify gaps, ensure compliance, safety, and ongoing process improvements, as well as leading and developing lower-level management staff and high performing teams.
This position is responsible for managing the operations of the Post Market Compliance functions, such as Field Actions, Stability Testing, Adverse Event Reporting, Post-Market Surveillance, and Product Complaints. The role maintains collaborative relationships with the other functional areas and is responsible for overseeing the activities of their assigned teams to ensure the effectiveness of the Quality System. This position develops plans to manage work assignments and processes to meet productivity standards, quality goals and department objectives. Responsible for providing support to staff, resolving operational and performance issues, and implementing improvements to operations, processes, and the work environment. Trains and onboards new staff, assesses performance of direct and indirect reports and provides development opportunities. Ensures business goals, deadlines and performance standards are met. Communicates and collaborates with lower-level management, staff, department Senior Leadership, and other Autoimmunity functions to meet goals and produce the highest quality products and services. Ensures staff comply with company policies and expectations. All activities are performed in accordance with standard operating procedures, Quality System, safety, and administrative regulations.
Key Accountabilities
• Department Management
• Implements strategies to achieve company objectives. Ensure staff understand objectives and expectations related to them.
• Manages department headcount budget to ensure effective resource planning, including recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management.
• Ensures effective use of company’s performance management program, including setting expectations, providing timely and meaningful feedback, ensuring understanding, holding staff accountable, while supporting employees’ development goals.
• Educates and broadens the Quality, Compliance, and technical knowledge within the teams; develop and deploy personnel skill assessment and training plans.
• Ensures regular and meaningful communication throughout team, and with department management, through effective use of one-on-one meetings, team meetings and other forms of formal and informal communication.
• Manages and leads lower-level management staff to ensure high performing teams and department operations. Includes accountability to Werfen’s People Manager Competencies and Expectations.
• Monitors department personnel and operations to pre-empt employee issues. Proactively manages employee relations issues; uses judgement in consulting with department senior leadership and Human Resources.
• Assesses the need for new or improved operations. Delegates responsibility or may directly author, implement, and ensure maintenance of departmental procedures, work instructions, and templates associated with the quality assurance activities.
• Develops metrics and data collection methodologies, interprets data to make recommendations to Department Senior Leadership and prepare reports on the performance of the quality system, including management-requested reports and management review meetings minutes.
• Proposes department budget and monitors department expenditures.
• Continuous Improvement
• Reviews trends, analyzes and identifies continuous improvement opportunities and coordinates/performs actions to improve processes and metrics; proactively manages critical quality issues.
• Contributes, manages, and executes proactive quality strategies and plans.
• Creates and maintains productive relationships with other departments and promotes collaboration within Autoimmunity and other Werfen manufacturers and Affiliates.
• Ensures risks to Quality Systems are identified and mitigated through effective controls.
• Influences and drives cross-functional projects for quality improvement.
• Recommends Quality objectives and ensure they are monitored and achieved.
• Ensures Quality System effectiveness through audits, data analysis, and projects to achieve company and department objectives.
• Complaints
• Provides technical and administrative guidance to product complaint personnel on complaint investigation strategies and resolution. Ensure escalation of product issues, timely and appropriate customer communications, and accurate investigation and corrective action docume
Location: San Diego, CA
Posted: Oct. 21, 2024, 9:21 p.m.
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