|
Apply online for the
Senior Manager QA
position and advance your career in the
Biotech industry today.
|
Senior Manager QA : MedImmune, LLC.
|
| Job Number |
02256 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Santa Clara
California
|
| Salary (year) |
|
| Start Date |
3/1/2010 |
| Industry |
Biotech |
| Job Type |
Operations-Quality |
| Relocation |
Not Required |
|
MedImmune, LLC.
View all jobs from MedImmune |
|
|
|
| Apply Online |
| What Does Your Boss Say About You? |
| Description |
Description
Title: Senior Manager, QA
Location: CA, Santa Clara - NON SALES
Req: 02256
Position Summary:
Major Duties and Responsibilities (including supervising others):
Responsibilities and experience may include the following: Auditing (internal and external - utilizing risk based strategy. Document systems. Change management utilizing a risk based approach. Operational Excellence utilizing tools such as DMAIC and root cause analysis. Quality at the source utilizing on the floor real time review and investigations. Electronic system utilizing tools such as Trackwise, SAP, and LIMS. Product release utilizing systematic process flows. Line management and staff supervision includes scheduling, recruiting and performance management. Approve SOPs, batch record and deviations. Organizing work systems. Strong time management skills. Managing the supplier qualification program.
• Support the Quality function in the areas of supplier audits, supplier qualifications, internal audits and regulatory inspections
• Perform other initial and ongoing qualification requirements and risk/compliance assessments
• Provide technical expertise to resolve issues related to non-compliance and corrective and preventative actions.
• Inspection readiness support for regulatory inspections of company and contractors
• A thorough understanding of the GMP requirements and guidance for US and EU markets
• High degree of organization and flexibility with the ability to prioritize responsibilities as needs require
• An understanding of the vaccine/biotechnology/pharmaceutical industry and its unique business responsibilities.
• Excellent technical writing skills
• Ability to work with clients of diverse incumbent skill base
• A thorough knowledge of product development, manufacturing, handling and control
• A working understanding of validation concepts for equipment, processes, methods, and products
• Ability to collaborate with site leads as well as all others in company-wide initiative implementations
• Ability to accurately determine resource requirements, including time, space and personnel
• Ability to design and interpret approach quality metrics for all events
• Maintain the MedImmune Quality Systems to ensure that clinical and commercial products meet Federal, EU, and company standards
• Support Operations in the validation, manufacture, control, release and distribution of vaccines. Assure that all appropriate records and documentation required to ensure lot control and traceability are adequately maintained and managed.
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.
|
|
| Requirements |
Position Requirements
Special Skills/Abilities:
• Experience with various quality systems
• Excellent technical writing skills
• Working knowledge of MS Word, Excel, PowerPoint, and quality trending software
• cGMP experience and the ability to work independently as well as in a team environment
• Applies critical thought to solving problems of complex scope and analysis of situations
Job Complexity: Highly technical
Supervision:
• Generally accomplishes results through lower management levels.
• Determines, establishes organizational structures and supervisory relationships, subject to management approval
• Works under limited supervision and must be able to work independently.
(Supervision required, level of independence)
Educational Requirements
Requirements/Qualifications:
Education: Bachelor of Science in biology, microbiology, virology, chemistry, engineering, or related fields.
Experience: Minimum 8 years previous biopharmaceutical quality assurance/systems experience. 5 years in a managerial role. Leadership experience desirable
|
|
| Contact Info |
|
|
|
Apply online at company website |
|
Find More Biotech Jobs in the Biotech industry.
|
|