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.

About the role

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 ensures alignment with overall business goals.

Responsibilities

• 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.
• Manages and monitors IGIV Manufacturing operating budget.
• Meets all production and release requirements, maximizing yields and efficiency and reducing quality issues.
• Partners with the Quality and Manufacturing Assurance groups to review deviation investigation reports for accuracy and identify root cause/corrective actions for IGIV Purification related incidents.
• Builds organizational competency and succession plans.
• Participates in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
• Provides 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.
• Partners 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 communication. Must be able to read, write, and speak English. Must have strong technical writing skills.
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
• Strong organizational, analytical and problem-solving skills.
• Ability to analyze details and perform structured decision-making on a daily basis.

Occupational Demands

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently sits for 6-8 hours per day.
• Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.
• Occasionally walks.
• Occasionally bends and twists neck.
• Light to moderate lifting and carrying objects with a maximum lift of 25lbs.
• Frequently drives to site locations, frequently travels within the United States, occasional international travel.
• Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others, relates sensitive information to diverse groups.
• Ability to apply abstract principles to solve complex conceptual issues.
• Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Pay

The estimated pay scale for this role based in California is competitive and commensurate with experience. Additionally, the position is eligible to participate in up to a specified percentage of the company bonus pool.

Benefits

• Medical, Dental, Vision, and life insurance.
• Paid Time Off (PTO) and paid holidays.
• Up to 5% 401(K) match.
• Tuition reimbursement.