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QA Validation Manager
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QA Validation Manager : MedImmune, LLC.
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| Job Number |
02129 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
1/18/2010 |
| Industry |
Biotech |
| Job Type |
Operations-Quality |
| Relocation |
Not Required |
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MedImmune, LLC.
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| Description |
Description
Title: QA Validation Manager
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02129
Position Summary
The QA Validation Manager is responsible for directing validation manager, specialists, and engineers to manage the validation program at MedImmune Gaithersburg. The Validation Manager interacts with different departments to ensure all GMP testing and manufacturing facilities, equipment and utilities are fully qualified to support ongoing projects. Responsibilities include personnel scheduling, forecasting project requirements, and preparation of validation projects including ownership of the Site Master Validation Plan. The Validation Manager assures that facilities, laboratory equipment, utility systems and process equipment are validated and that reports are written. The Validation Manager is responsible for preparing and controlling the annual validation budget and for project coordination with MedImmune staff and outside consultants as necessary.
Additionally, the Validation Manager will also be responsible for the Site Change Management system.
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. 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.
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| Requirements |
Position Requirements
Essential Job Duties
• Manage day-to-day operations of validation services
• Manage operations and technical services to minimize downtime of plant equipment
• Manage the validation activities including start-up, protocols/reports, thermal studies, cleaning validation, process equipment, utilities and QC instruments
• Present overviews of validation programs to regulatory agencies as necessary
• Training employees to assure up-to-date knowledge of practices and procedures
• Develop a staff capable of implementing company and quality objectives
• Controls the QA Validation budget
• Develop and implement risk based validation strategies
• Develops a competent staff capable of implementing company and quality objectives
• Communicate effectively to management across departments staff goals, priorities and policy
• Performing risk assessments of new products entering the facility
• Process mappings
• Leading the Site Change Management system
Additional Job Functions
• Assure that clinical trial material facilities, laboratory equipment, utility systems and process equipment are validated, calibrated, and that reports are properly written
• Assure project coordination with MedImmune staff and outside consultants
• Mentor and coach site-based technical personnel to enhance performance relative to validation projects
Requirements/Qualifications
• Must be knowledgeable and proficient in the methods and management of validation and control processes
• Must be familiar with product development and manufacturing systems
• Must demonstrate strong organizational skills and demonstrate the ability to manage multiple projects and meet timelines with minimal supervision
• Must be able to interpret P&ID, Isometrics, and “As Built” drawings
• Must be familiar with latest industry standards on validation
• Must be knowledgeable with FDA cGMP and European regulations and guidelines
• Must possess excellent management communication, interpersonal, and organizational skills
• Must have experience in the preparation of the validation portions of regulatory submissions
Educational Requirements
Education and Experience:
• Master's degree in engineering/chemical engineering, or in directly related discipline
• Minimum of 7 years experience in a manufacturing or validation role within a commercial/clinical biopharmaceutical production setting
• Working knowledge of quality systems and cGMPs
Special Skills/Abilities:
• Good listening skills, interpersonal savvy and peer relations
• Ability to effectively present and communicate complex data, technical materials and strategy to large groups
• Professionally communicate verbally and in writing, and represent the function effectively
• Strong presentation skills for small and large groups
• Profound project management skills
• Ability to adapt to changing priorities
• Develop and lead teams
Travel Requirements:
• Must be able to travel up to 20% to various manufacturing locations
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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