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Clinical Program Manager
1 week ago
Providence Petaluma, United States**Description** · Provides professional, comprehensive nursing care for patients in an acute care environment. Accountable for the delivery of coordinated, safe, compassionate, therapeutic, evidence-based quality care to patients and families. · Providence caregivers are not simp ...
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Clinic Operations Manager
1 week ago
Health Right 360 San Francisco, United StatesHealthRIGHT 360 gives hope, builds health, and changes lives for people in need by providing comprehensive, integrated, compassionate care that includes primary medical care, mental health services, and substance use disorder treatment. · The Integrated Care Center Clinic is a fe ...
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Clinical Operations Manager
2 days ago
Mochi Health San Francisco, United StatesIn a world where healthcare can feel like a maze of bureaucracy and frustration, Mochi Health offers a refreshing oasis. We're not just another telehealth clinic - we're on a mission to rewrite the script on healthcare, starting with the most overlooked areas of medicine. With a ...
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Clinical Case Manager
2 days ago
Kaiser Oakland, United StatesJob Summary: · Provides mental health assessment, diagnosis, treatment and crisis intervention services for adult and/or child members who present themselves from psychiatric evaluation with a broad range of mental health needs. Collaborates with treating physician, psychiatric ...
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Clinical Case Manager
3 days ago
Felton Institute San Francisco, United States**Job Description**: · **Clinical Case Manager - GOS** · **Geriatric Outpatient Services - Senior Division** · **Agency Overview** · Founded in 1889, Felton (formerly Family Service Agency of San Francisco) is the oldest nonsectarian, nonprofit charitable social-services provider ...
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Clinical Case Manager
2 days ago
Kaiser Oakland, United StatesJob Summary: · Provides mental health assessment, diagnosis, treatment and crisis intervention services for adult and/or child members who present themselves from psychiatric evaluation with a broad range of mental health needs. Collaborates with treating physician, psychiatric ...
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Clinical Case Manager
2 days ago
Kaiser Oakland, United StatesJob Summary: · Provides mental health assessment, diagnosis, treatment and crisis intervention services for adult and/or child members who present themselves from psychiatric evaluation with a broad range of mental health needs. Collaborates with treating physician, psychiatric ...
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Manager Pulmonary Clinical Services
1 week ago
Veracity Santa Rosa, United States**Manager Pulmonary Clinical Services** · **Onsite** · **Santa Rosa, CA** · Manages staff in providing delivery of high quality, patient-focused, and cost-effective pulmonary care services in a widely diverse culture across the CSA. Accountable for service area and across the con ...
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Manager- Pulmonary Clinical Services
4 days ago
conglomerate IT Santa Rosa, United StatesJob Title: Manager - Pulmonary Clinical Services · Location: Santa Rosa, CA · Employement: Full Time - Permanent · Manages staff in providing delivery of high quality, patient-focused, and cost-effective pulmonary care services in a widely diverse culture across the CSA. Accounta ...
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Clinical Nurse Manager, Emergency Department
1 week ago
MarinHealth Medical Center Greenbrae, United States**Clinical Nurse Manager, Emergency Department, Full-Time, Days**: · **Greenbrae, CA**: · **ABOUT MARINHEALTH a UCSF Affiliate** · Come and be a part of our healing team at the award-winning MarinHealth Ranked in the top 3% of general hospitals in the country, we have made great ...
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Senior Clinical Trial Manager
3 days ago
Ultragenyx Pharmaceuticals Inc. Novato, United StatesPosition Summary: · ultrafocused - Work together to fearlessly uncover new possibilities · The Senior Clinical Trial Manager (CTM) is responsible for providing leadership to one or more Study Management Teams (SMTs). The Senior CTM is responsible for the day to day management of ...
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Technical Manager, Clinical QA
1 day ago
Talent Software Services Novato, United StatesTechnical Manager, Clinical QANovato, CA6 monthsJob Responsibility: Create revise and approve BioMarin Phase Appropriate Quality Systems documentation Represent Clinical Quality Department in cross functions forums. Draft and approval of Quality Technical Agreements with CDMOs as ...
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Technical Manager, Clinical QA
1 week ago
Talent Software Services Novato, United StatesTechnical Manager, Clinical QA · Novato, CA · 6 months · Job Responsibility: · Create revise and approve BioMarin Phase Appropriate Quality Systems documentation · Represent Clinical Quality Department in cross functions forums. · Draft and approval of Quality Technical Agreemen ...
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Technical Manager, Clinical QA
1 week ago
Talent Software Services Novato, United StatesTechnical Manager, Clinical QA · Novato, CA · 6 months · Job Responsibility:Create revise and approve BioMarin Phase Appropriate Quality Systems documentation · Represent Clinical Quality Department in cross functions forums. · Draft and approval of Quality Technical Agreement ...
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Technical Manager, Clinical QA
1 week ago
Biomarin Novato, United StatesWho We Are · BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutti ...
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Technical Manager, Clinical QA
1 week ago
BioMarin Pharmaceutical Novato, United StatesWho We Are · BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutti ...
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Technical Manager, Clinical QA
2 days ago
Intelliswift Software Inc Novato, United StatesHybrid role - 3 days a week onsite · Create revise and approve *** Phase Appropriate Quality Systems documentation · Represent Clinical Quality Department in cross functions forums. · Draft and approval of Quality Technical Agreements with CDMOs as required for internal suppor ...
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Physical Therapist/Clinic Manager
5 days ago
Revel Staffing Pinole, United StatesJob description · We are currently seeking qualified Physical Therapist candidates to join our growing team in the Pinole area. We are looking for both Staff PT's and a Clinic Manager. Whether you are an experienced clinician or a brand new graduate, we are the right place for yo ...
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3633 Technical Manager, Clinical QA
1 week ago
Harvest Technical Services Novato, United StatesHybrid role - 3 days a week onsiteJob Description:Create, revise and approve the company's Phase Appropriate Quality Systems documentation. Represent Clinical Quality Department in cross functions forums.Draft and approval of Quality Technical Agreements with CDMOs as required fo ...
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Rn Hospice Clinical Director
4 days ago
Ethos Novato, United States**RN Hospice Clinical Director** · Our **RN Clinical Director** will guide our interdisciplinary team members, collaborating closely with your Program Director, Hospice Physician, and Community Liaisons. · You will champion office excellence, foster growth in patient numbers, and ...
Technical Manager, Clinical QA - Novato, United States - Intelliswift
Description
Job ID:
Hybrid role - 3 days a week onsite Create revise and approve *** Phase Appropriate Quality Systems documentation Represent Clinical Quality Department in cross functions forums.
Draft and approval of Quality Technical Agreements with CDMOs as required for internal support Provide quality oversight for internally manufactured early-stage products and starting materials Provide support to audits and inspections of CDMOs and internal manufacturing and testing organizations Provide quality oversight of one or more portions of operations including, but not limited to: Release clinical phase 1 and 2 materials ensuring compliance with phase appropriate lot release requirements.
Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities.QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs.
Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.Perform QA Walkthroughs for 300 BMK manufacturing product changeovers Review and approval of SOP revisions initiated by manufacturing, Facilities and Engineering and Analytical support for 300 BMK Operations Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments.
Ensure manufacturing and adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus). 7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions. Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required. Computer literacy required, including Microsoft PowerPoint, Word, Excel. Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues. Results oriented; effectively manages a multitude of projects efficiently. Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported. Experience managing internal and external project stakeholders. Excellent written and verbal skills; ability to communicate effectively with all levels of the organization. Builds relationships with other functions, shares best practices, and solves shared problems. Demonstrates in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally. Demonstrates substantial knowledge of industry best practices and trends. Positive, solution focused outlook on daily challenges.
