- Actalent (Alameda, CA)
- Job Title: Compliance QA Specialist - GxP QualityJob Description The Compliance QA Specialist will play a crucial role in supporting GxP inspection and audit ... in monitoring supplier performance. + Assist in tracking and trending quality metrics related to supplier qualification, audits, and inspection programs. Essential… more
- Genentech (South San Francisco, CA)
- …is located in** **South San Francisco, on-site.** **The Opportunity** + Provide quality and compliance oversight for external GxP suppliers, including CMO, ... services from suppliers, and decommissioning. + Oversee all required quality activities during the lifecycle of a GxP... quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission),… more
- Sumitomo Pharma (Sacramento, CA)
- … GxP systems supporting Clinical Supply Chain, Commercial Operations, Quality Management, and Manufacturing. + Lead the integration strategy and execution ... and Chain of Identity (CoI)-crucial in CGT-into compliant and scalable system solutions. GxP , Quality & Compliance + Own and enforce GxP compliance for all… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead's Chief Compliance Officer on healthcare compliance execution. + Promote a culture of GxP quality across R&D with the highest levels of integrity to meet ... visibility and drive continuous improvement. + Serve on Enterprise Quality Council, representing R&D, to enable end-to-end GxP... Quality Council, representing R&D, to enable end-to-end GxP oversight and contribute to integrated quality … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Responsibilities:** **Strategic Leadership & Governance** + Define and lead the global GxP training strategy aligned with corporate quality objectives and ... The Director, GxP Training Lead, is a senior leader within...leader within the Learning Center of Excellence under Global Quality . This role is responsible for developing and executing… more
- Datavant (Sacramento, CA)
- …Director of Quality , you will own the implementation and evolution of GxP -aligned quality practices that support regulated data services and software. This ... Datavant is seeking a strategic and hands-on **Director of Quality ** to lead product and supplier quality ...QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. + Manage and mentor a… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with exposure to both small molecule and biologics. + Strong knowledge of GxP regulations, quality systems, and risk management principles. + Proven experience ... **Job Summary** The Associate Director, Quality Operations will lead initiatives that drive operational...operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- The Associate Director, GxP Training, is a critical member of the Learning Center of Excellence within Global Quality . This role is responsible for developing ... and maintaining robust training programs that ensure compliance with Good Practice ( GxP ) regulations across the organization. The position will lead the design,… more
- MetaOption, LLC (Sunnyvale, CA)
- …for log aggregation, threat detection, and support of regulatory audits (HITRUST, GxP ). * Collaborate with security, quality assurance, and regulatory teams ... reliability, scalability, and compliance of critical systems in alignment with FDA GxP guidelines and HITRUST standards for healthcare data protection. You will lead… more
- Lilly (South San Francisco, CA)
- …+ Publications on model validation, benchmarking, or reproducibility + Experience with GxP compliance and quality management systems + Exceptional attention to ... detail and commitment to scientific rigor + Strong technical writing skills for regulatory documentation + Portfolio mindset balancing rigorous validation with rapid deployment for partner value This role is based at a Lilly site in Indianapolis, South San… more
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