Director, IGIV Production

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Job Summary: 

 

Responsible for direct leadership over Bulk IGIV manufacturing operations, ensuring production goals are achieved through current Good Manufacturing Processes. Creates and/or maintains an overall strategy plan for their area of responsibility and ensure alignment with overall business goals.

 

Essential Job Duties:

• Oversees the 24/7 day-to-day operations of the Bulk IGIV manufacturing group, evaluating performance towards the achievement of production goals while maintaining regulatory compliance and minimizing errors.
• Assumes the decision-making responsibility for day-to-day operations considering staff input and collaborating closely with other functions (i.e. Quality, Maintenance, Validation, Engineering, etc).
• Directly supervises IGIV manufacturing managers and supervisors, including hiring, developing, and motivating in a manner that promotes the achievement of IGIV manufacturing’s business goals and objectives.                                           
• Manage and monitor IGIV Manufacturing operating budget.                                                                
• Meets all production and release requirements, maximizing yields and efficiency and reducing quality issues.                 
• Partner with the Quality and Manufactruing Asurance groups to review deviation investigation reports for accuracyand identify root cause/ corrective actions for IGIV Purification related incidents.                                                                          
• Build organizational competency and succession plans.                                                                      
• Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsible
• Provide scientific and/or technical advice and counsel regarding projects as needed                                                                         
• Develops and challenges managers and supervisors to find ways to improve manufacturing efficiency and reduce costs while maintaining product quality and compliance.
• Maintains clear communication with the VP of Manufacturing regarding goals, projects, planning, and overall performance of the bulk manufacturing group.
• Actively develops the capabilities of the staff, while creating an environment where employees want to work—one that supports engagement, job satisfaction, professional growth, and a culture of trust, respect, and accountability.
• Improves product quality and maintains compliance with respective federal and international regulations for cGMP's, governmental compliance and corporate standards.
• Assures a high level of safety awareness, compliance and performance by providing training and leadership in the prevention of accidents by assuming a proactive approach to safety and injury prevention.
• Partner with the Quality group to approve or reject all revisions and changes to IGIV Purification processes, procedures, specifications as well as Validation protocols and reports that will allow or disallow the use of facilities, equipment , materials or processes.                                                                                                 

Requirements:

• Master’s degree or Ph.D. in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or related scientific/technical discipline..
• Minimum 10 years of operations experience in an FDA regulated manufacturing facility - pharmaceutical, biologics, biotech, or medical device industry.  Minimum 5 years of managerial experience in an FDA regulated environment.
• Strong knowledge of cGMPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
• Project management experience. 
• Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates. 
• Excellent verbal and written comm