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Manager, Site Quality Assurance Systems
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Manager, Site Quality Assurance Systems : MedImmune, LLC.
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| Job Number |
02180 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Frederick
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Operations-Quality |
| Relocation |
Not Required |
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| Description |
Description
Title: Manager, Site Quality Assurance Systems
Location: MD, Frederick - NON SALES
Req: 02180
Major Duties and Responsibilities (including supervising others):
Essential Job Functions:
· Experienced people manager with good listening skills, interpersonal savvy, and peer relations.
· Lead and implement quality system continual improvement initiatives and risk assessment programs. Interface with other functional areas to assist with related quality improvement and assessment activities at both the site and corporate levels.
· Effective manage modern quality systems, including nonconformance, deviations, change controls, audits and continual improvement systems. Defines and reviews quality system metrics to track performance and for trend identification.
· Assists with site inspection readiness.
· Ensures that all site related Quality Assurance activities are conducted in compliance with corporate standards and applicable regulations.
· Provides expertise and guidance in interpreting government regulations and guidelines, both US and ROW.
· Performance of internal and external GMP audits utilizing a risk based strategy
· Develops, coaches and trains personnel to ensure that adequate technical understanding is built in to day-to-day operations.
· Manages and measures work through metrics along with good overall time management.
· Supervises and trains QA Specialists. Performs training and development of QA Specialists to ensure compliance, personnel growth as well as improving technical understanding.
Additional Job Functions:
· Skilled in operational excellence tools and uses them to drive quality improvements.
· Independently identifies and resolves complex problems through good decision quality utilizing both functional and scientific technical skills.
· Skillful with conflict management and resolution and is not afraid stand alone on issues.
· Proven track record in developing or leading teams with an ability to lead multiple teams within and outside the organization.
· Ability to work collaboratively with strong listening skills.
· Able to professionally communicate verbally, in writing and represent the function effectively.
· Ability to effectively present complex data and strategy to large groups.
· Establishes group goals and objectives, ensuring they support company goals and objectives
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
Special Skills/Abilities:
Biopharmaceutical processing, Biological Safety Testing, Biopharmaceutical Analysis, Industrial Microbiology, Quality Systems, Regulations and Technical Guidance
Job Complexity:
Work is performed without appreciable direction. Determines site quality objectives, and interprets company policies. Completed work is reviewed, from a relatively mid-long-term perspective, for desired results.
Responsible for the successful operations activities of importance to the site and organization. Is actively involved in daily site operational activities.
Decisions could affect the financial, employee, or public relations posture of the site. Erroneous decisions or recommendations would result in major delays to assigned projects resulting in considerable expenditure of additional time, human resources and funds.
Conducts briefings and technical meetings for top management and customer representatives. Interacts with senior-level managers concerning matters of significance to the site. Collaborates and provides input to corporate on quality standard and policy setting.
Supervision:
Generally accomplishes results through lower management levels.
Educational Requirements
Requirements/Qualifications:
Education:
BSMS/Ph.D: Biochemistry, Virology, Biology, Chemistry or similar degree in another Life Science or Engineering techincal area required
Experience:
7-10 years in Quality, with 4-5 years in a managerial role with prior experience in:
· Application of Operation Excellence and risk management tools and techniques.
· Developing or re-designing Quality Systems.
· Successfully developing KPIs for both internal and external processes
· Global GMP regulations and industry best practice.
· Interfacing with USA, EU and ROW Regulatory Authorities.
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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