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Quality Assurance
1 week ago
University of California San Francisco San Francisco, United StatesThe Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization's products and/or development processes. QA deliverables and mana ...
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Quality Assurance Manager
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub functions. · • Partners ...
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Quality Assurance Manager
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. · • Partners ...
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Quality Assurance Specialist
1 day ago
Actalent San Mateo, United States Full timeDescription: · Role and Responsibilities: · • Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements. · • Review executed productio ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeQuality Assurance Specialist · HYBRID role, onsite in Foster City, CA · Description: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilanc ...
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Quality Assurance Specialist
6 days ago
Actalent San Mateo, United States Full timeDescription: · 20% BRR · 80% Analytical focused · • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements · • Serves as QA Lead for clinical and commercial projects. · • Leads quality investigations/deviations/ ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. · Performs or provides support for product complaint inve ...
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Quality Assurance Specialist
6 hours ago
Actalent San Mateo, United States Full timeDescription: · • Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients · • Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations · • ...
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Quality Assurance Specialist
1 week ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaint from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to the Pharmacovigilance Department. Performs or provides support for product complaint investigations · ...
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Quality Assurance Specialist
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Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for Gilead products from the US and Canadian markets.Documents in Gilead Quality System for investigation for product complaints and triages safety events to Gilead Pharmacovigilance Department. Performs or provides support for product ...
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Quality Assurance Specialist
3 days ago
Actalent San Mateo, United States Full timeDescription: · ● Receives product complaints for products from the US and Canadian markets. · Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investi ...
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Quality Assurance Manager
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Bayview Hunters Point Foundation for Community Imp San Francisco, United States**What We Do**: · Bayview Hunters Point Foundation has been at the heart of social justice for over 50 years, providing support services for predominantly low-income people of color in the Bayview and throughout San Francisco. · Our mission is to build a community that is empower ...
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Manager, Quality Assurance
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Cutera Brisbane, United States**Company Description** · We're Growing - With Growth Comes Opportunity · **Job Description** Position Summary**: · The individual is responsible for activities that lead to, and maintain compliance to/with Cutera's Quality Management System and maintains regulatory approval to m ...
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Quality Assurance Manager
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SLAC National Accelerator Laboratory Menlo Park, United StatesQuality Assurance Manager · Job ID · 5681 · Location · SLAC - Menlo Park, CA · Full-Time · Regular · **SLAC Job Postings** · **Position Overview:** · The SLAC Quality Assurance Manager is responsible for providing leadership, vision, management, direction, oversight and strategic ...
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Quality Assurance Engineer
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Pharmaceutical Quality Assurance Manager
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Employee Quality Assurance
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Employee Quality Assurance
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Infinity Systems Pleasanton, CA, United States Freelance"Take your career to the next level with Pleasanton, CA. · RONALGROUP - Leader in lightweight wheels. · When it comes to lightweight wheels, no one can compete with us - as the market leader and partner of all renowned car brands, we set new standards with our innovations and com ...
Manager, Clinical Quality Assurance - Menlo Park, United States - Corcept Therapeutics
Description
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR).
In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing syndrome).Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases.
With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advance the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
The Manager of Clinical Quality Assurance (CQA) is a key member of the CQA team and will perform day-to-day clinical quality operations and compliance activities to support the success of the clinical studies sponsored or supported by Corcept.
Responsibilities:
Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)
Serve as a QA representative and support clinical study teams to provide compliance adviceParticipate in review and approval of clinical study documents and clinical SOPs / Guidance DocumentsManage study-specific Study Audit Plans compliance for the assigned program by using a risk-based approach for Corcept clinical studiesReview and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on timeLead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellenceManage and support inspection readiness activities for GCPSupport clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigator site inspections, and contract research organization (CRO) inspectionsSupport GMP, GLP, and PV inspectionsLead clinical non-compliance event investigations and CAPA implementationPerform quality metric analysis for CQA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical dataMaintain a contemporary knowledge of agency and industry trends, standards, and methodologies related to GCPs.
Understanding of Quality Systems that support GCP quality activitiesExperience developing GCP processes for the best industry practices and trainingStrong proficiency in Microsoft OfficePreferred Education and Experience: BS / BA (science or related field) or equivalent experience6 or more years clinical research experienceThe pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $170,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at:
is an Equal Opportunity EmployerCorcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
