Manager, Manufacturing Assurance

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.

 

POSITION SUMMARY

 

The Manager, Manufacturing Assurance is responsible for the review of all investigations for deviations, environmental monitoring excursions and calibration investigations related to Manufacturing, Maintenance and Packaging and assessing the impact on product and/ or production.

 

ESSENTIAL DUTIES & RESPONSIBILITIES include the following. Other duties may be assigned.

• Oversees the completion of investigation reports, including identification of product impact root causes and determination of corrective actions.
• Work closely with the Manufacturing, Quality Assurance, Maintenance/ Facilities, and other departments to ensure prompt closure of deviation reports.
• Identify areas where deviation/corrective maintenance reoccurrence could be avoided.
• Review manufacturing, facilities, environmental monitoring documentation and other documentation, as required, to ensure it supports the investigation reports generated by the team.
• Manage and monitor department's operating budget.
• Assume the decision-making responsibility for day-to-day operations considering staff input and collaborating with other GBI functions.
• Provide scientific and/or technical advice and counsel regarding projects as needed.
• Communicates company and departmental goals to the department's exempt and non-exempt employees.
• Communicates with cross functional departments and support groups to improve departmental performance and efficiency.
• Maintain current knowledge of regulatory and industry standards.
• Review investigations, reports generated for out-of-specification results or out-of-procedure events.
• Participate in regulatory and internal inspections/audits including providing written responses for area of responsibility, if necessary
• Provide guidance and hands-on training to direct reports.
• Appraise and monitor performance of department personnel.
• Coach, counsel, address complaints and resolve employee related issues with the collaboration of Human Resources, as necessary.
• Provide a leadership role ensuring employee health and safety.
• Involved in interviewing/selection process of hiring or promoting department personnel.
• Strict adherence to procedures and practices according to FDA regulations.
• Strong emphasis on documentation according to FDA regulations.
• Adhere to departmental corporate safety policies.
• Work closely with Quality Assurance on the Quality Risk management Process in gathering, organizing and reporting of Risk associated with deviations, unusual events, or similar, as needed

 

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

 

• Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific/technical discipline is required.
• Minimum of 5 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required.
• Minimum of 3 years of managerial, supervisory, or leadership experience in a related industry is required.
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
• Requires an in depth understanding of pharmaceutical manufacturing/ packaging and laboratory processes/ equipment (ultrafiltration, CIP, chromatography, reactor tanks, centrifuges, filter presses, etc.)
• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
• Direct hands on experience in manufacturing, packaging, validation, and/or aseptic processing i