Quality Assurance Technical Manager

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:

 

Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation required to meet submission timelines.  Review and approve Validation and Research & Development documents. Perform compliance reviews of Validation CAPAs for confirmation that all action items were satisfactorily addressed and verify the completeness and accuracy of information. 

 

Essential Job Duties:

 

• Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation required to meet submission timelines. 
• Review and approve validation IQ, OQ, PQ, CQ, FEQ, AMF and PV protocols and reports.
• Perform compliance reviews of Validation CAPAs for confirmation that all action items were satisfactorily addressed and verify the completeness and accuracy of information. 
• Interface with various groups to ensure that content in complex technical submissions and information requests to the FDA and other regulatory agencies is accurate and complete.
• Participate in regulatory and internal inspections/audits including direct discussions with auditors and providing written responses as applicable for area of responsibility.
• Maintain current knowledge of FDA, EU and other regulatory agencies and industry standards.
• Release approved regulatory changes in SAP for implementation in manufacturing
• Review and approve R&D stability and characterization protocols and final reports.
• Provide scientific and/ or technical advice regarding projects and validations as needed.
• Author and/or edit Standard Operating Procedures (SOPs), License Specifications (LSs), regulatory submissions and other documents.

 

Job Requirements:

 

• Bachelor’s degree in the sciences or related field. 
• Minimum 5 years’ experience in Quality Assurance, Regulatory Affairs, Compliance, Quality Engineering or Quality Control, in the pharmaceutical or biotech industry, with a strong emphasis on cGMP and GLP concepts.
• Comprehensive knowledge and understanding of cGMPSs, FDA, EU and other regulatory agency requirements, and industry guidelines. 
• Ability to work independently with minimum supervision. 
• Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment. 
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines. 
• Strong technical writing and interpersonal skills with the ability to interact with personnel at all levels.  Excellent verbal and written communication skills. 
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Provide regular status updates to senior management.  
• Maintain a quality presence to ensure compliance with all regulatory requirements.

 

The estimated pay scale for the Quality Assurance Technical Manager role based in L