Director, Quality Systems & Regulatory Compliance
Cytokinetics, Inc.
Cytokinetics, Inc. is seeking a senior leader to steer the Quality Systems organization, ensuring QMS governance, document control, and GxP training are effective and compliant. The role emphasizes cross-functional collaboration, performance coaching, and strategic process improvements across the company. The ideal candidate has extensive experience in quality systems within regulated life sciences, with a proven track record in leadership, regulatory readiness, and data-driven quality #J-18808-Ljbffr Cytokinetics, Inc.
- ...clinical and commercial milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and lead our quality and compliance strategy.... ..., and systems to ensure compliance with global regulatory standards. You will provide strategic oversight over inspection...SuggestedWork at officeLocal areaRemote work2 days per week
$225k - $262.5k
...Responsibilities Provide strategic roadmap for the Quality Systems organization, including oversight of quality... ...practices. Ensure Quality Systems support compliance with applicable FDA, EMA, ICH, GxP, and other relevant regulatory requirements. Oversee the document control...Suggested- Senior Manager, Quality System & Compliance Heartflow is a medical technology company advancing the diagnosis and management of coronary artery... .... As the Senior Manager of Quality System and Quality (Regulatory) Compliance , you are a pivotal leader responsible for the...SuggestedFor contractorsWork experience placementFor subcontractorLocal areaWorldwideRelocation
- Cytovale, Inc. in South San Francisco, CA is seeking a Head of Quality and Regulatory to own the QMS and serve as the Management Representative.... ..., and post-market activities for the IntelliSep system and consumables. You will lead a cross-functional quality organization...Suggested
$210.38k - $272.25k
...improving the lives of patients for generations to come. As a Director, AI Systems Quality & Governance, R&D and Gilead, you will establish and... ...regulated industry.Familiarity with Clinical Operations, Regulatory Affairs, Patient Safety, Clinical Data Management,...SuggestedFull timeFor contractorsLocal areaFlexible hours$210.38k - $272.25k
...DescriptionDirector, Global Supplier Quality Management ProgramPosition ImpactThe Director, Global Supplier... ...governance, processes, systems, quality documents, and... ...and enhances quality, compliance, supply continuity, and... ...supply continuity, and regulatory compliance.Key...Full timeFor contractorsLocal area- ...than 750,000 patients worldwide. The Director, Clinical Quality & Compliance is responsible for the strategic... ...of clinical quality assurance and regulatory compliance programs across pre-market... ...managing protocol deviations, CAPA systems, and UADE/SAE safety reporting within...Work experience placementWork at officeLocal areaWorldwideRelocationShift work
- ...Job Description Head of Quality and Regulatory Cytovale, Inc. | South San... ...: Quality and Regulatory Compliance Location: Bay area, onsite... ...'s Quality Management System and serves as the company's... ...Working alongside the Senior Director of Regulatory Affairs, the...
- ...cardiovascular biopharmaceutical company seeking a Director of Quality Systems to lead the QMS, document control, and GxP training... ...will partner with IT to optimize the eQMS and ensure compliance with cGMP and regulatory standards. The role requires senior leadership,...
- ...employment. Position Director/Senior Director of Quality Operations Location... ...Neurona. This role ensures GMP compliance across day-to-day... ...internal procedures and regulatory expectations. Partner... ...manufacturing and analytical testing systems within a GMP environment....
$158.7k - $172.1k
...Senior Manager electronic Quality Management System (eQMS) Nurix Therapeutics is a clinical stage... ...commercialization of Nurixs products in compliance with relevant US EU and ICH this role... ...across Technical Operations Clinical Regulatory Affairs and other cross-functional...Full timeWork at office- Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager, electronic Quality Management System (eQMS) to drive quality systems across the development and commercialization lifecycle. You will oversee Deviations, Investigations, CAPAs, Change Controls, Complaints,...
- ...dysfunction. The Manager of GxP Training, Quality Systems supports the administration,... ...accurate, effective, and aligned with regulatory requirements, business needs, and established... ...routinely reviewed for accuracy and compliance. Create, review, and refine GxP functional...Contract work
- ...international shipping, customs compliance, and warehousing. Our... ...Responsibilities: # Upgrade service qualities and workforce efficiency for... ...needs # Participate in system integration projects for... ...Strong understanding of legal, regulatory, and compliance frameworks....Contract workLocal area
$225k - $262.5k
...Cytokinetics seeks a Director of Quality Systems to lead quality management, document control, and GxP training functions. The role provides strategic oversight of quality systems operations, regulatory compliance, and team development within a specialty cardiovascular...- Sr. Project Manager - Quality Management Systems Full-time We are focused on imparting effective business staffing services through high level... ...experience Veeva QMS and Sparta (either Stratas or 123 Compliance) Must have a minimum 6+ years experience with either Veeva...Full time
- Executive Director GCP Quality Assurance Job Title: Executive Director, Clinical Quality Assurance 3 days onsite in South San Francisco... ...their entire lifecycle, ensuring risk management, regulatory compliance, and effective oversight. This position will be responsible...Contract workLocal areaRelocation package
$190k - $205k
...site 3 days/week. About the Role: The Associate Director, Quality Systems is responsible for establishing and leading Osanni's hub quality... ...in supplier qualification and audits and in supporting regulatory inspections. ~ Track record building quality systems...Full time3 days per week$150k - $175k
...looking for an experienced Manager of Quality Management Systems to build, maintain, and improve our... ...across all disciplines and support regulatory initiatives. You will also design and... ...focused on audit, training, and compliance.Oversee QMS compliance for all personnel...Local area$273k - $290k
...inflection point.We are looking for a Senior Director of Quality Assurance to build a pragmatic,... ...accountable for building insitro’s Quality systems: standing up our QMS and SOPs,... ...evolving algorithms that hold up under regulatory scrutinyExecutive & Cross-Functional LeadershipSupport...Home officeFlexible hours3 days per week$171k - $223k
...role delivers strategic GCP quality oversight across Denali's clinical... ...the GCP Quality Management System. Providing strategic... ...lifecycle. It sets the standard for compliance and ethical conduct across study... ...partners, translating regulatory expectations into practical,...Remote jobLocal area$260k - $275k
...We are looking for a Sr. Director, Quality Assurance (QA) to join our... ...phase‑appropriate quality systems that support compliant development... ..., Quality Control, Regulatory, Clinical Supply, and external... ...laboratories to identify and elevate compliance risks, enable proactive...Contract workFor contractorsWork at officeShift work$170k - $225k
...design, build, and operate the world’s largest autonomous logistics system, delivering critical supplies quickly and reliably. Today,... ..., and test planning to improve campaign execution and decision quality.• Be extremely adaptive to new hardware, new programs, and getting...Local area$194k - $253k
...Job Overview The Clinical Quality Lead will play a crucial role... ...of quality and ensuring that compliance is embedded throughout the R&... ...relevant industry standards, regulatory guidelines, and company Standard... ...Supports Quality Management System (QMS) including quality...Worldwide- ...Senior Director, Quality As the Senior Director, Quality, you will serve... ...'s Quality Management System (QMS) and providing oversight... ...functionally with Manufacturing, Regulatory, Clinical Operations,... ...Operations. Quality Systems & Compliance: ·Own and continuously...
- ...been a “sleepy” industry for decades is now at the epicenter of sustaining the global economy. About the Role: As a Manager of Systems Test Engineering at Mytra, you will be responsible for leading a team of systems test engineers in developing and executing systems...Work at office
- ...South San Francisco, CA is seeking a Director, Clinical Quality Assurance to lead the Clinical QA... ...oversees quality programs, ensures regulatory compliance in international environments, and... ...policies, procedures, and quality system elements. The position requires a life...
$145.7k - $220k
...organizational leader to oversee our Quality Assurance team. Reporting to the Head... ...scale our overarching Quality Management System (QMS) across all manufacturing and... ...Quality Assurance Senior Manager will drive regulatory compliance, internal and external auditing...Full timeTemporary work$280.2k - $319.8k
...Senior Director Quality Control Nurix Therapeutics is a clinical stage... ...establishing operations systems and a team to support programs... ...small molecule QC strong regulatory acumen and proven experience... ...supply continuity or GMP compliance; drive risk mitigation strategies...Full timeFor contractors$260k - $320k
The Sr. Director, GCP Quality Assurance oversees the development, implementation... ...of quality assurance systems and activities that support... ...clinical trial quality, GCP compliance, and program-level quality... ...readiness. Provides guidance on regulatory standards, compliance...Local area
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