Lead the Commissioning, Qualification and Validation (CQV), Cleaning, Sterility assurance and Computer System Validation (CSV) teams at a site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments.
Requirements
- Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks
- Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints
- Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change
- Continuously improve the culture of the Validation team and the site
- Represent Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)
- Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings
- Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations
- Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members
- Direct support to OST head or lead annual OPEX budget for Validation department
- Effective delegation and building confidence and competence within direct reports
- Drive engagement in the technical and personal development of the Validation team and members
- Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members
- Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives
- Continuously improve the culture of the Validation team and the site
Benefits
- Comprehensive benefits package
- Estimated annual base salary as a new hire ranges from $129,500 to $156,800
- Additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options
