Head of the QA Application Management:
Job Summary:
Defines, plans and/or coordinates activities involving the global implementation of modern Quality Computer systems (TrackWise, SAP, MES) used for QA business activities in the pharmaceutical industry to further global competitiveness, product quality and patient safety. Support Development, Implementation and Maintenance of the Quality IT Roadmap in support of the PT Roadmap and following PPM, Agile and PT IT portfolio processes. Provide leadership and guidance for quality oversight and support of computer systems used in the GMP environments to ensure compliance with Policies and Requirements. Drive continuous improvement through experimentation and innovation of systems that enable business process agility.
Key Responsibilities/Tasks:
Direct and participate in continuous improvement initiatives for Roche Global Computer Systems that support the Quality Assurance focused business processes
Demonstrate Lean Leadership Behaviors and drive continuing implementation of LPS
Identify, lead or participate in cross functional projects, process improvements or new system design/rollouts in support of functional or network goals and business needs
Develop strategies for new QA related IT System projects and for maintaining systems that are consistent with Roche policies, standards and procedures
Identify opportunities for enhancement of quality systems performance, usability and productivity through implementation and refinement of IT applications
Lead and partner with internal and external partners to understand IT System business needs, gap prioritization and delivery solution
Approve and oversee improvements to Quality operational policies, plans and procedures as systems are being optimized
Provide input and rationale for department budget.
Provide input for the development of overall Quality objectives and long-range goals
Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance
Manage and administer all aspects of people processes related to the employee life cycle.
Selection, hiring and training of personnel on company and department policies, systems and processes, goal setting, providing feedback).
Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Provide guidance and coaching to teams on the topics of QA systems, Quality requirements and Master Data Management
Qualifications/Requirements:
B.S. or B.A. degree (preferably in Life Science)
12+ years of relevant experience in the pharmaceutical or biopharmaceutical industry
Working knowledge of one or more informational packages (ie QMS, EDMS, MES, ERP)
Sound knowledge of cGMPs or equivalent regulations
Demonstrated knowledge and execution of Quality operations and processes
Experience in coaching, influencing (with or without authority) and motivating successful quality organization functions with demonstrated leadership in building successful collaborations with internal and external partners
Demonstrate use of LPS Lean Leadership Methods to drive continuous improvement
Demonstrate sound judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicate, influence and escalate issues and decisions as needed
Experience working in validated or controlled environments
Ability to interpret and relate Quality Policies and requirements for implementation and review
Ability to communicate clearly and professional both in writing and verbally
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Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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