Associate Director, Strategic Operations

The Associate Director, Strategic Operations is responsible to manage the production support of Viral Vector and Cell and Gene Therapy products under cGMP conditions. They are expected to plan and manage scheduled tasks (technology transfers, capital projects, production support and readiness, continuous improvement projects, deviations), and assign duties to manufacturing project leads, points of contact, and deviation investigators to meet the production schedule and approved/procedural timelines. Serving as a member of the Manufacturing Leadership Team, the incumbent will be responsible for leading the technology transfer, continuous improvement, and strategy development of all operations associated within areas of responsibility. The Associate Director, Strategic Operations drives, through the deviation investigation team, thorough root cause analysis of issues and robust corrective actions/preventive actions.

Description:
 

• Leads the Quality strategy for site expansion and process improvement projects with the objective to drive a forward looking organizational development of the Quality Unit (Quality Assurance, Quality Operations and Quality Control), a proactive development of the Quality System, an effective execution of customer interactions and simplification of processes.
• Drives superior standards for quality improvement projects, manage in collaboration with the QLT and the assets the quality improvement project portfolio at site originating from the risk register and as outlined in the business unit and Site Quality Plan.
• Develops and manages an effective and efficient meeting organization in Quality including tracking of actions and their closure. Facilitate key Operational Excellence integrated programs such as Critical Chain, Program reviews and Management of the daily meetings.
• Partners closely with the assets and functions at site and support the Quality Leadership team in daily execution. Act as a strong partner to the Manufacturing Operations teams (Viral Vector & Cell Therapy) and other teams that support operations (e.g. Quality Control, Materials Management, Engineering, Validation and Quality Systems).

Key Responsibilities:

• Implements the overall quality strategy for the facility expansion projects.
• Partners with the Site Director, Head of Quality and Senior Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy.
• Acts as the lead Quality SME for significant quality or compliance issues within the facility expansion projects.
• Identifies and lead the implementation of QA improvement projects that impact both the Cell Therapy and Viral Vector assets in a manner consistent with global quality systems, Lonza Corporate requirements and standards and current regulatory requirements (primarily US FDA and European requirements) and others as needed
• Works across the quality function to improve the Quality Operations/Quality Control customer interaction models to improve the overall customer experience.
• Oversee the consolidated Quality reporting on behalf of the site and assets and according to global system requirements
• Drive cross-functional collaboration on Quality Strategic projects for Assets and aligned with Site Business Strategy.
• Drive financial excellence in Quality
• Supervise timely escalations on behalf of the site in line with Lonza Group Procedures
• Manage any Staff projects on behalf of the Site QA Head

Key Qualifications:

• Bachelor's Degree in Life sciences, engineering, or related fields
• Experienced knowledge of biopharmaceutical manufacturing experience and/or quality operations or quality systems working in a GMP environment
• Management of Quality Assurance Staff

• Display ability to incorporate rapid changes in priorities into the QA Ops projects or schedule of activities and to communicate those changes in a positive way to the staff.

• Ability to support efforts in other functional areas

  when needed and assume additional responsibilities at times to support a project or sudden transitions of personnel.

• Ability to suggest new ideas for improvements or to make recommendations for an identified compliance concern.

• Ability to communicate status, needs, forecasts, risks and timelines effectively to management.

• Deliver data as appropriate demand planning or staffing

  planning.