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Protocol Link, Inc.
San Francisco, CA, United States
SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing Protocol Link, Inc. 10/17/2023 Job Description Must have 10+ Years ofrelevant experience Leadthe R&D Quality and Manufacturing team to manage GCP (good clinicalpractice) and GPV (good pharmacovigilance practices) inspections by globalregulatory health authorities. Providestrategies and
Job Source: Protocol Link, Inc.Protocol Link, Inc.
San Francisco, CA, United States
SME Lead, Regulatory, Clinical R&D, Quality & Manufacturing Must have 10+ Years ofrelevant experience Leadthe R&D Quality and Manufacturing team to manage GCP (good clinicalpractice) and GPV (good pharmacovigilance practices) inspections by globalregulatory health authorities. Providestrategies and oversight for global planning-preparations and c
Job Source: Protocol Link, Inc.BigHat Biosciences
San Mateo, CA, United States
Development Program and Operations Manager Department: Drug Development Employment Type: Full Time Location: San Mateo, CA Description The Role: We are seeking a talented and experienced Program Manager with extensive expertise in biologics cGMP and Chemistry, Manufacturing, and Controls (CMC). The ideal candidate will also have strong lea
Job Source: BigHat BiosciencesEPM Scientific - Phaidon International
San Francisco, CA, United States
Vice President of Quality and Regulatory Affairs San Francisco Bay Area (Hybrid) Our client is a cutting edge CAR-T who novel approach dramatically decreases the time and cost associated with manufacturing. This is a newly created position allowing you to get in on the ground floor and eventually build a team beneath you as their indications advanc
Job Source: EPM Scientific - Phaidon International89bio
San Francisco, CA, United States
THE COMPANY 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being develope
Job Source: 89bioSkydio
San Mateo, CA, United States
Skydio is the leading US drone company and the world leader in autonomous flight, the key technology for the future of drones and aerial transportation. The Skydio team combines deep expertise in artificial intelligence, best-in-class hardware and software product development, and operational excellence to empower a broader, more diverse audience o
Job Source: SkydioInnova Solutions
San Rafael, CA, United States
Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs Position type: Full time Contract Duration: 6 months Location: San Rafael, CA As a Associate Director, Regulatory Affairs , you will: Job Description: Regulatory Strategy Development Lead the development, integration, execution and maintenance of the glo
Job Source: Innova SolutionsComforcehealth
San Rafael, CA, United States
Associate Director, Regulatory Affairs - Biotech/R&D/Science Job ID: 942863 San Rafael , California Job Type: Contract Added - 02/21/24 Job Description Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs Position type: Full time Contract Duration: 6 months Location: San Rafael, CA As a Ass
Job Source: ComforcehealthSan Francisco, CA, United States
Must have 10+ Years of relevant experience
Lead the R&D Quality and Manufacturing team to manage GCP (good clinical practice) and GPV (good pharmacovigilance practices) inspections by global regulatory health authorities.
Provide strategies and oversight for global planning-preparations and clinical investigations.
Build systems and tools to support and oversee end-to-end inspection readiness and inspection management training.
Develop staff competencies and capabilities in inspection readiness, inspection conduct, and CAPAs. Collaborate with teams and SMEs to investigate and resolve inspection readiness gaps prior, during and post inspection. Support CAPA development and perform CAPA effectiveness checks for inspection findings.
Contribute regulatory and quality strategies for the preparation of inspection risk assessments for senior management and key stakeholders.
Review QMS (Quality Management System) policies and processes for inspection readiness
Provide as-needed liaison to client’s partner and vendor inspections.
Work Schedule
Full time (40 hrs/week)
4 days/week on-site
Remote for remaining time
Location: San Francisco Bay Area
Duration: 6 months
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Email Alert for SME Lead Regulatory Clinical RD Quality Manufacturing jobs in San Francisco, CA, United States
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