Quality Strategy Lead for CROs & Regulatory
SonoThera
SonoThera in the United States is seeking an Associate Director, Quality to lead QA activities, oversee the implementation of a Quality Management System, and ensure compliance with FDA, ICH, GLP, GMP and GCP across CROs in a fast-paced biotech setting. You will build quality programs from the ground up, manage CRO partnerships, drive documentation control, SOP development, and risk-based oversight with a focus on speed, reliability, and data integrity in preclinical through clinical development. #J-18808-Ljbffr SonoThera
$182.1k - $338.3k
...Principal Content & Evidence Submission Strategy Lead is focused on developing the medical... ...Maintain accountability for work product quality, timeliness, and budget, providing guidance... ...silos, interpret external legal and regulatory landscapes, and lead cross-functional...QualityRegulatoryFull timeLocal area- Genentech is looking for a PDQ Principal Quality Lead in South San Francisco, CA. This role requires a seasoned... ...professional to develop and execute quality strategies, manage audits, and ensure compliance with regulatory standards. Applicants should have at least 10 years...QualityRegulatory
- ...Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies...QualityRegulatory
- ...document completeness, and drive governance through SOPs, metrics, and CAPA processes, partnering with Clinical Operations, Quality, Regulatory Affairs, and IT to support scalable, compliant trials. The role emphasizes inspection readiness, regulatory alignment, and mentorship...QualityRegulatory
$186k - $235k
...Therapeutics in South San Francisco seeks an Associate Director of Medical Writing. The role includes leading the development of regulatory documents and performing quality control reviews to ensure compliance. The ideal candidate will have over 5 years of experience in...QualityRegulatory$197.7k - $367.1k
...and delivered with the highest quality and resilience. The... ...translating complex product strategies into actionable results with... ...of leaders. What You'll Do Lead and manage a portfolio of cross... ...technical, finance, supply chain, regulatory, and manufacturing. Design and...QualityRegulatoryWork experience placementLocal area$163k - $236k
Develop strategy, and roadmap and drive execution of opportunities to compensate high quality youth creators maintaining high standards of safety and responsibility.Serve as... ...innovate within an ever-changing global regulatory landscape, turning complex safety challenges...QualityRegulatory$127.5k - $236.9k
...Communications; Policy, Evidence & Access Strategy; Channel & Contract... ...As the PX Vendor Management Lead (SE7) within PX Delivery, you... ...partners) to ensure high-quality patient support. You will drive... ...terms, SLAs, compliance, and regulatory requirements alongside Legal,...QualityRegulatoryFull timeContract workLocal areaRelocation package3 days per week$158.2k - $293.8k
...Roche!The OpportunityThe PDQ Principal Quality Lead supports the Roche/Genentech Organization... ...development and delivery of Quality strategies, audits and conclusions for entities (e... ...goals and initiatives, and management of regulatory authority inspections.Responsibilities...QualityRegulatoryFull timeLocal areaRelocation package$207.1k - $384.5k
...DEPCS delivers scalable and regulatory-ready innovations that enhance... ...As the Therapeutic Area (TA) Lead for Ophthalmology within the... ...imaging, and patient-centered strategies supporting the therapeutic area... ...Digital/PCOR), ensuring high-quality and timely deliveryYou set...QualityRegulatoryFull timeLocal areaRelocation package- Genentech is seeking a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatory’s Quality & Compliance capability to lead the development and maintenance of the QMS... ..., and align risk-based quality strategies with global standards. You will...QualityRegulatory
- ...Director, Regulatory Affairs Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation)... ...the global regulatory lead (GRL) for the immunology... ...compliant, high quality, nonclinical and clinical... ...colleagues, including CROs to deliver sound,...QualityRegulatoryFor contractorsWork at office
- AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) to lead regulatory strategy development and execution for US and Canada products. You will coordinate with FDA, support filings, and advise cross-functional teams on regulatory issues...Regulatory
- Nurix Therapeutics, Inc. is seeking a Director of Regulatory Affairs (Strategy, Immunology & Inflammation) to lead global regulatory strategy and execution across immunology programs. You will guide nonclinical and clinical submissions, coordinate with internal teams,...Regulatory
- ...is hiring for a Director, CMC Quality Control - Small Molecules to provide... ...commercialization. You will lead governance for CMOs/CLs, ensuring compliant QC strategies, data integrity, and phase-... ...cross-functional collaboration for regulatory submissions, inspections, #J-1...QualityRegulatory
$302.01k - $390.83k
...California.Executive Director, PDM Product Strategy LeaderKEY RESPONSIBILITIESReporting... ...(PDM) organization, this role leads strategic cross-functional teams responsible... ...development activities along with regulatory, supply chain, and quality strategies and plans in alignment...QualityRegulatoryFull timePart timeFor contractorsLocal areaWorldwide- ...Responsibilities: Lead the data quality evaluation by investigating all clinical... ...timelines Define the strategy and lead the preparation of data package for regulatory submission Represent... ...Clinical Data Management in CROs or Pharmaceutical Industry...QualityRegulatoryFor contractors
- Kardigan is looking for an Associate Director, Regulatory Strategy to support regulatory strategies and ensure high-quality deliverables. You will collaborate cross-functionally and manage submission timelines while reporting to the Executive Director, Regulatory. The...QualityRegulatory
- ...compliance with GCP/ICH and regulatory requirements. Key Responsibilities... ...meetings. Manage CROs and vendors to ensure performance... ...contracted scope, timelines, quality, and budget expectations. Contribute... ...risks, develop mitigation strategies, and proactively manage study...QualityRegulatoryLong term contract
$111k - $167k
...predictive, and precise. Description The Regulatory Compliance Lead is a technically grounded individual... ...with engineering, product, and quality teams to operationalize regulatory requirements... ...and developing proactive mitigation strategies to maintain a strong regulatory...QualityRegulatoryFull time- A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive development as a regulatory... ...project teams, and developing regulatory strategies. An ideal candidate will have at least 10...Regulatory
- ...Francisco seeks an Associate Director in Toxicology to lead nonclinical safety strategies for multiple programs. You will play a key role in interpreting... ...program decisions that ensure patient safety and regulatory success. The ideal candidate holds a PhD with 10+ years...Regulatory
- ..., Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based in... ...Francisco, you will partner with Regulatory Affairs, Quality, and Clinical teams to ensure compliant INDs, CTAs...QualityRegulatory
- ..., Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. You... ...develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross-functional partners to...QualityRegulatory
- ...Statistical Methodology Data Scientist in California to lead the development and institutionalization of... ...and mentor junior staff while shaping the methodological strategy and external collaborations in line with regulatory expectations. #J-18808-Ljbffr Jobleads-USRegulatory
- ...Director of Clinical Data Management to lead data delivery and integrity across multiple studies. This role shapes strategy, budget, and resources for CDM,... ...with senior stakeholders to ensure high-quality data and regulatory readiness. Strong leadership and vendor...QualityRegulatory
- Nurix Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to develop and execute global regulatory strategy and lead high-quality submissions. You will partner with SVP Regulatory Affairs and cross-functional...QualityRegulatory
- Maze Therapeutics is seeking a senior regulatory medical writer to lead the function across development programs. You will develop high-quality clinical and regulatory documents and... ...Biostatistics, and Safety to align on program strategy and data interpretation while driving...QualityRegulatory
- ...Director of Biosample Operations in South San Francisco to safeguard biosample data quality for Phase I-IV trials. Lead vendor oversight, guide biosample strategy, and partner with QA/Regulatory to ensure GCLP and GCP compliance across clinical programs. You will manage lab...QualityRegulatory
- ...South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for our US and global... ...commercialization plans. The candidate will oversee high‑quality CTA/IND and BLA/MAA filings for biologics,...QualityRegulatory
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