Under the direction of Inspection Manager, the Inspection Supervisor will be accountable for the safe, cost-effective, and efficient operation of the inspection operations, while in full compliance with current Good Manufacturing Practices and Genentech quality policies and standards.
Ensure work environment meets Genentech and industry standards. Participate in the development of safety goals and manage operations so that all site goals are met. Trend safety performance and reinforce safety practices throughout the department. Provide oversight to ensure adequate resources and priorities for safety improvement initiatives.
Ensure facility is always regulatory inspection-ready. Review trend data to ensure quality compliance and correct negative trends as required. Reinforce quality practices throughout the department. Develop and maintain cGMP training requirements for staff. Maintain strong alliances with the Quality organization.
Maximize production output and labor efficiency while meeting required safety and quality levels.
Participate in the development of production, productivity, and financial goals and manage operations so that all site goals are met.
Review and approve manufacturing documentation including tickets and SOPs. Review and support closure of manufacturing variances and incident reports.
Manage the monthly production plans, production activity control, and shop order sequencing to optimize use of available capacity.
Manage the performance planning process for all direct reports. Coordinate department level hiring and staffing plans. Actively participate in the Talent Review process.
Complete all required training activities (i.e., safety, cGMPs, technical skills, processing operations, etc.). Ensure lessons learned or best practices are shared across the organization. Leverage knowledge to maximize organizational effectiveness. Foster an environment that encourages continuous learning.
Manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production.
Manage departmental spending against approved budgets. Participate in the business review and budget development process for the plant.
Qualifications / Requirements:
BS in a science or engineering discipline or equivalent.
Possess a minimum of 3 years of progressively responsible experience in pharmaceutical manufacturing and specific experience in parenteral manufacturing preferred.
Demonstrated ability to manage people and projects. Current understanding of FDA and EMEA guidelines, cGMP's for Manufacturing Parenteral Drug Products, including validation requirements.
Operational Excellence and Industrial Engineering Skills.
Excellent written/spoken communication and interpersonal skills.
Proficiency with validated change management, discrepancy management, inventory management, and production control systems.
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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At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.