SR DIRECTOR, PRODUCTION

RESPONSIBILITIES:

• Establishes and controls the processes and procedures for compounding, aseptic and terminal sterilization filling, component preparation, capping, lyophilization.
• Oversees the site Formulation and Filling activities and performance of staff to ensure the achievement of plant objectives and performance goals are met.
• Accountable for departmental annual budget,
• Analyzes information and reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports and makes recommendations for overall improvement.
• Assists Plant Manager and Regional Executives in defining organizational goals and strategic plans. Failure to achieve goals will have critical impact on success of functional area(s) and organization.
• Maintains compliance with Company policies, cGMP's, SOP's, safety standards and good housekeeping practices.
• Initiates immediate action and communications if data integrity issues or critical deviations from regulatory requirements or quality systems are discovered.
• Approves instructions relating to production operations and to ensure their strict implementation.
• Ensures that products are produced and stored according to Marketing Authorizations, product dossiers, or specifications is carried out, that all operations are recorded and that the associated records are evaluated.
• Ensures qualification, calibration, and maintenance of production facilities and equipment.
• Ensures appropriate cleaning and process validations are performed and periodically monitored.
• Ensures that the required initial and continuing training of production personnel is adapted and completed.
• Approves facilities, utilities, and equipment for use after qualification, calibration, repair, maintenance, and activities.
• Facilitates inspections and audits.
• Has managerial oversight on plant operations by being present in the manufacturing areas.
• Conducts continuous review and follow-up on projects to ensure completion of work.
• Informs all appropriate personnel of department's plans, programs and operations that affect their areas, and encourages feedback from staff to increase productivity and quality.
• As part of Top Management, you have the overall responsibility and accountability for all aspects of the Health, Safety, Environment, Energy, and Quality Management Systems, including the following:
• Taking overall responsibility and accountability for the prevention of work-related injuries and ill health, the protection of the environment, as well as the provision of safe, harmless, and healthy workplaces,
• Ensuring that the Health, Safety, Environment, Energy, and Quality Management Systems' policies and related objectives are established and are compatible with the strategic direction of the organization

REQUIREMENTS:

• Bachelor of Science degree in related field or equivalent education and experience.

• Minimum of 12 years' experience in pharmaceutical manufacturing in a cGMP environment required.
• 5-10 years' experience in aseptic operations required.
• Must demonstrate progressive levels of managerial experience and broad span of organizational control.
• Terminal sterilization and lyophilization experience preferred.
• Expert business knowledge with comprehensive understanding of the organization and functional area(s) analytical and technical skills.
• Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment to meet plant and company objectives.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.