Senior QC Manager

Manage the operations of the QC laboratory product testing group. Provide leadership and supervision for direct reports. Ensure the laboratory meets all GMP requirements. PRINCIPAL DUTIES:1. Manage the day to day operations of the QC Product Testing group. 2. Ensure the daily operations in the laboratory – performance of testing and sampling, review and reporting of data, completion of assay trend charts and associated documentation are completed in a timely manner to support customer needs. 3. Ensure appropriately qualified personnel are in place. Ensures and provides personnel development and goals and objectives for group.4. Ensure laboratory equipment is calibrated and maintained according to standard operating procedures. 5. Conduct and participate in GMP audits in the facility.6. Ensure OOSs and deviations are investigated and documented within established timeframes.7. Ensure existing procedures are followed with recommendations and implementation of modifications for improved efficiency and modernization. 8. Ensure the laboratory is adequately supplied and manages within the department budget.9. Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.10. Adheres to Company safety procedures and guidelines on a daily basis.Requirements/Qualifications:Business Skills1. High degree of organization and flexibility with the ability to prioritize responsibilities as needs require. 2. An understanding of the basic business concepts and techniques as they relate to human resource, objectives, appraisals, etc. A working understanding of company goals, strategies and orientation. An understanding of the pharmaceutical industry and its unique business and social responsibilities.3. The ability to effectively manage, lead, nurture, discipline and praise subordinates.Technical Skills1. An understanding of the requirements outlined in Part 211 of the Federal Register cGMP's For Finished Pharmaceuticals, and their practical application during manufacture, testing, and distribution. The ability to evaluate facilities, records, processes, procedures and practices for conformance to these requirements. 2. Identifies and troubleshoots equipment problems.3. Identifies and troubleshoots adverse assay trends.4. Identifies technical problems and follows through to find solutions.5. Prepares validation protocols, executes experiments, and prepares validation reports.6. Responsible for writing new standard operating procedures or revising existing documentation.7. Prepares documentation for presentation to Regulatory Agencies.Teamwork1. The ability to effectively communicate (written or oral) and interact with individuals both internal and external to MedImmune, one-on-one, and in team environments. 2. Summarizes data at Department meetings and participates, as requested, in project team meetings.3. Regularly rEducation:Bachelors or Masters degree in the sciences.Experience:Requires at least 8 years of laboratory related experience in the biologics industry and at least 1 year of managerial experience. Experience in a regulated environment is preferred.CLICK HERE TO APPLY MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Senior QC Manager Location:  US-MD-Gaithersburg Status:  Full Time, Employee Job Category:  Sales/Retail/Business Development