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Senior Manager, Quality Compliance & Global Change Control Systems Job
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| Employer Name: ComplianceCrossing |
SpiderID: 2353334 |
| Location: Palo Alto, California |
Date Posted: 7/8/2008 |
| Wage: |
Category: Miscellaneous |
| Job Code: |
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Job Description:
Implement and manage the Stiefel Global Product Change Control System, including changes to those global products that are manufactured by Stiefel Network manufacturing sites as well as those products that are manufactured by Stiefel authorized Contract Manufacturers and marketed globally. Champion and support the corporate initiative to harmonize change control practices worldwide through close cooperation with individual local Quality, Regulatory, Supply Chain, IT and R&D leaders. Develop and manage a standardized change control implementation strategy to improve consistency and detail of global implementation plans. Prioritize change control requests based on business needs and promote cross-functional Subject Matter Expert assessments to facilitate regulatory submissions and GMP compliance. Develop, implement and monitor Key Performance Indicators and metrics for the global change control process. Coordinate activities of and prepare technical assessments for Global Change Control Governance Board. Develop, utilize and continually improve SOPs and change control tools including databases, effectiveness check surveys, trending assessments, etc. Be the local Stiefel West Coast (SWC) resource for Quality Compliance programs and host for on-site regulatory or internal inspections/audits. Provide oversight of the SWC Clinical Compliance program. Implement and manage the local SWC Corrective and Preventative Action (CAPA) program and GxP Training program. Coordinate local SWC Quality Investigations programs as needed. Perform other duties as assigned by management. Must be able to work independently and as part of a team. Ability to work on multiple projects simultaneously is essential. Excellent organization skills. Requirements A 4-year degree in the sciences or associated disciplines and 10 or more years experience in the pharmaceutical industry with 3 to 5 years hands-on experience in a cGMP environment.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: ComplianceCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.compliancecrossing.com
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