Sr Mgr Quality

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Senior Manager Quality Assurance oversees, manages, and ensures the successful day-to-day operations of Quality Assurance department including QA Operations (batch review), QA Label Control (label review), QA Document Control, QA Release, and Quality Engineering (Deviation, APR/AR, Change Control, CAPA, and KPI Metrics). The Senior Manager ensures the success of the teams by oversight and development of the Managers, Supervisors and Individual Contributors.

Job Description

Performance of Functional Area & People Are Appropriate for Business Needs

Staff Aligned to Organizational Goals:  Translates the corporate vision, values and goals into day-to-day activities and behaviors; guides and motivates others to take actions that support the vision, values and goals.  Holds regular team meetings to ensure staff are kept in the loop. Performance Managed:  Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.  Develops coaching partnerships with direct reports.  Provides training and development plans.  Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review.  Change Leader:  Acts as a champion for change. Encourages employees to question established work processes or assumptions; challenges employees to ask “why” until underlying cause is discovered; involves stakeholders in continuous improvement actions and alternatives. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities. Resources Allocated to Ensure Critical Priorities Are Met:  Ensures money, technology, and staff are allocated to achieve optimal results. Culture of Continuous Learning & Improvement:  Anticipates talents, skills and knowledge that will be needed in the organization; delegates tasks and responsibilities to others to grow skills while at the same time managing risk and establishing appropriate controls. Right People Selected & Onboarded: Ensures a clear and effective job description is developed prior to beginning recruitment efforts.  Conducts thorough interviews that enable clear selection decisions; ensures onboarding processes drive rapid time to full productivity. Communication:   Creates an atmosphere in which timely and high-quality information flows smoothly up and down, inside and outside of the organization; encourages open expression of ideas and opinions.

Safe, Effective Product Releases

Ensures the Quality Assurance groups successfully monitor the quality of all manufacturing and packaging activities including executing batch manufacturing and packaging records in accordance with specified timelines. Continually seeks ways to improve the Quality Culture of the site. Ensures the Quality Assurance groups successfully issue and control labels and labeling confirming that issuance is on time and accurate. Ensures the Quality Assurance groups successfully performs batch disposition activities to meet specified timelines. Ensures the batch disposition process is robust and continually seeks ways to improve the disposition process both in terms of effort expended, timeliness of disposition, and quality of work performed/quality of the disposition.

Effective, Efficient Quality System

Ensures the timely review of SOPs, work instructions, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements, where applicable. Establishes meaningful goals and metrics for groups in conjunction with the Site Quality Director, and manages the performance to those goals. Ensures the development, documentation and implementation of standardized processes for key business functions.  Develops quantitative techniques to monitor process performance. Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change contr