GxP Compliance QA Director: Global Inspection Readiness
Exelixis Inc
Exelixis Inc in California is seeking a Compliance QA Director to oversee GxP inspection readiness, manage regulatory inspections, and ensure preparedness for global health authority audits. The successful candidate will have significant experience in quality compliance and will lead cross-functional teams in supporting inspection activities. In this role, you'll develop and execute strategic inspection readiness plans while providing compliance guidance across departments related to GxP processes. Excellent communication and organizational skills are essential for success. #J-18808-Ljbffr Exelixis Inc
$190k - $269k
Overview The Compliance QA Director leads the company’s GxP inspection readiness, ensuring ongoing preparedness for global health authority inspections. This role manages regulatory inspections and responses, directs internal audits and mock inspections, and provides oversight...SuggestedContract workWork experience placementWork at officeLocal areaFlexible hours$190k - $269k
## Compliance QA DirectorApplylocations: Alameda, CAtime type: Full timeposted on: Posted Yesterdayjob... ...of the job):*** The Compliance QA Director leads the company’s GxP inspection readiness ensuring ongoing preparedness for global health authority inspections. This role...SuggestedContract workFor contractorsWork experience placementWork at officeLocal areaFlexible hours$190k - $269k
Exelixis, Inc. is seeking a Compliance QA Director in Alameda, California, to lead GxP inspection readiness and regulatory inspections. You will develop inspection readiness plans and manage internal audits while providing compliance guidance and oversight. The ideal candidate...Suggested$133k - $189k
Summary / Job Purpose The Compliance QA Manager, QA Core, is responsible for coordinating and maintaining inspection readiness activities and provides support for assessing proposed corrective... ...of 5‑8 years of related experience in GxP quality assurance or quality compliance,...SuggestedContract workWork at officeLocal areaFlexible hours- ...PURPOSE The Associate QA Operations Director - Labeling & Systems... ...Regulatory Affairs (RA), Global Patient Safety, etc.)... ...strategy across the GxP landscape to identify... ..., ensuring compliance with global regulatory... ...for Health Authority inspections and audits. Establish...SuggestedLocal area
$210k - $250k
The Director of Quality Assurance is a key leader... ...ensures that quality and compliance are effectively... ...systems, and adherence to global regulatory... ...extensive experience in QA Operations, complemented... ...and maintaining readiness for regulatory inspections. Building strong partnerships...Local area$200k - $235k
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...Chief Regulatory Officer, the Director, Regulatory Affairs - CMC-... ...developing and executing global Chemistry, Manufacturing, and... ...quality, consistency, and compliance with global regulatory... ...response documents Support inspection readiness activities, including coordination...$210k - $250k
...A leading biopharmaceutical company in Alameda, CA is seeking a Director of Quality Assurance. This role is responsible for leading quality assurance functions, ensuring compliance with GMP standards, and overseeing regulatory adherence. Ideal candidates have 15+ years...$145k - $214k
...manufacturing quality performance, inspection strategy, yield improvement,... ...experience or demonstrated readiness to manage and develop... ...tenure, and paid sick time in compliance with applicable law(s).... ...in Alameda, California, is a global healthcare company focused on...Temporary workWork at officeLocal areaShift work$95 - $102.53 per hour
...legislation to lead and execute GCP QA activities in support of global clinical trials by providing guidance... ...culture within Exelixis, provide compliance guidance and contribute to reaching a sustained state of inspection readiness. Responsibilities: · Partner...Contract workLocal area$246k - $349.5k
Senior Director, Clinical Operations Compliance Management (Biotechnology/Oncology) page is loaded## Senior Director... ...and is responsible for supporting inspection readiness activities, driving cross-study... ...of identified quality issues to QA. This Leader focuses on...Work at officeLocal areaFlexible hours- ...problem identification, resolution and own the quality business plan and continuous improvement efforts. Ensure all QA/QC members enforce timely inspection/audit activities, documentation control and written reports. Monitor the progress and effectiveness of the...For contractorsFor subcontractorLocal areaRemote workRelocation
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$125k - $155k
...& Beverage Manufacturing | Lead Quality Systems, Regulatory Compliance & Continuous Improvement This Jobot Job is hosted by: Ray Bahl... ...and performance. Support quality system audits and regulatory inspections. Other duties as assigned. Qualifications Needed: Bachelors...Local area- ...Architects seeks a highly organized Space Planning Manager for their Alameda office. This role involves leading the design process for global retail environments, managing design documentation, and fostering strong client relationships. The ideal candidate holds a degree...Work at officeFlexible hours
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Summary The Senior GCP/GVP QA Manager is accountable for assisting with the development... ...reports, including key GCP/GVP compliance and QA metrics. Determine approach to complex... ...preparation and submission activities for global regulatory filings. Excellent verbal, written...Local areaFlexible hours- ...I’m excited to announce that I am partnered with an innovative and rapidly growing biotechnology company seeking an Associate Director, Global Quality. This is a newly created leadership role driven by significant company growth, an expanding product portfolio, and...Remote work
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$117.5k - $185k
...on the development of associate tools, readiness and adoption plans to support deployment... ...delivery design and execution planning with Global Payments Solutions, Business Banking... ...issues. People Manager & Coach: Provides inspection, coaching and feedback to motivate, differentiate...Full timeWork at officeFlexible hoursShift workDay shift- ...is seeking an experienced PR manager to join their Public Affairs team in Alameda, CA. This role involves developing and executing global PR strategies for Abbott’s diabetes business, working closely with various stakeholders to enhance the company’s reputation. The ideal...
- Exelixis Inc in Alameda, California, is seeking an Associate QA Operations Director to provide quality assurance leadership for labeling and... ...extensive experience in the pharmaceutical industry, ensuring compliance with quality standards and managing complex quality events....
$124.5k - $177k
...Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and... ...programs and requirements, health authority responses, and global regulatory planning.**ESSENTIAL DUTIES AND RESPONSIBILITIES:***...For contractorsLocal areaFlexible hours- Scorpion Therapeutics is looking for a Regulatory Affairs professional responsible for developing and implementing global regulatory strategies aligned with corporate goals. This role involves direct interaction with regulatory authorities and managing regulatory submissions...
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$151k
...Requisition ID # 171517 Job Category: Compliance / Risk / Quality Assurance Job Level:... ...This position reports to the Director, Electric Investigations Job Responsibilities... ...+ years) in regulatory oversight, audit readiness, and leadership. Deep understanding of...Work experience placementWork at officeRemote workFlexible hoursNight shift- Fisica, Inc. in San Leandro, CA is seeking a Supervisor for Quality Control. This role entails overseeing all Quality Control inspection activities, ensuring adherence to quality standards. The ideal candidate should have 5-8 years of quality inspection experience and...
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