Director of GCP, Quality Assurance contract
2 weeks ago
Title: Director of GCP, Quality Assurance contract
Status: 12-month contract
Location: Hybrid South San Francisco 1-2 days a week onsite.
Hourly rate: $100-$115 per hour depending on experience
This is a hands-on position responsible for all assigned activities that ensure clinical trials adhered to applicable GCP regulations.
Other duties:
- Support managing a risk-based clinical Quality Management System (QMS) for GCP QA in compliance with applicable regulatory requirements (US and OUS), and company policies.
- Author and review Standard Operating Procedures through gap analysis.
- Continue to foster Plaints’ culture of continuous improvement with emphasis on efficiency and effectiveness.
- Achieve assigned deliverables of the Clinical QA function.
- Conduct or provide support of GCP, GCLP, GLP, and GVP audits of clinical investigator sites, Contract Research Organizations (CROs), contract clinical laboratories, and processes/systems to determine compliance status.
Required Skillsets:
- Bachelor’s degree required, advanced degree in a scientific field preferred. Quality assurance professional certification is a plus.
- At least 10 years of experience in Clinical Quality Assurance.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) and proposed (R3) for Good Clinical Practice. Experience with all phases of clinical trials.
- Knowledge and practical application of ICH E8 (R1)
- In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines.
All onsite employees and contractors to be fully vaccinated prior to their first day.
-
Director, Clinical Quality Assurance
5 days ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance...
-
Director, Clinical Quality Assurance
1 week ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...
-
Director, Clinical Quality Assurance
3 weeks ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.Alumis is hiring a Clinical Quality Assurance...
-
Director, Clinical Quality Assurance
2 weeks ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is...
-
Director of Quality Assurance
1 week ago
San Francisco, United States The Frank Group Full timeJob Description **Costco supplier experience a plus** The Director of Quality Assurance will play an integral part in the continued development and improvement of our quality assurance program. This role will require a deep understanding of quality management systems, a strong sense of urgency, and a passion for delivering products that exceed customers'...
-
Director, GMP Quality Assurance
3 weeks ago
South San Francisco, United States Alumis Full timeJob Description Job Description Salary: Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are...
-
Director, GMP Quality Assurance
2 weeks ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are seeking a Director of GMP Quality...
-
Director, GMP Quality Assurance
4 weeks ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are seeking a Director of GMP Quality...
-
Director, GMP Quality Assurance
4 weeks ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. We are...
-
Director of Compliance
4 weeks ago
San Francisco, United States Bayview Hunters Point Foundation Full timeJob DescriptionJob DescriptionDescription:Bayview Hunters Point Foundation: Who We Are: 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 empowered, clean,...
-
Quality Assurance Manager
3 weeks ago
South San Francisco, United States Shaw Bakers Full timeAbout Shaw BakersAt Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggressive, fast-growing company with a full pipeline of exciting new projects, products,...
-
Quality Assurance Manager
3 weeks ago
South San Francisco, United States Shaw Bakers Full timeAbout Shaw BakersAt Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggressive, fast-growing company with a full pipeline of exciting new projects, products,...
-
Quality Assurance Manager
3 weeks ago
South San Francisco, United States Shaw Bakers Full timeAbout Shaw BakersAt Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggressive, fast-growing company with a full pipeline of exciting new projects, products,...
-
Manager, Quality Assurance
4 weeks ago
San Antonio, Texas, United States Worldwide Clinical Trials - USA Full timeWho we are We're a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...
-
Quality Assurance Assistant
6 days ago
South Bend, United States Allied Physicians Surgery Center LLC Full timeJob DescriptionJob DescriptionCollaborates closely with and reports to the Director of Quality Management and Regulatory Compliance, Executive Director, Medical Director and Clinical Director. Assists Directors with developing and implementing Quality Improvement Plan and evaluates data and reports quarterly to Quality Improvement Committee. Attends meetings...
-
Director, Clinical QA
3 weeks ago
San Francisco, California, United States Proclinical Staffing Full timeProclinical are recruiting for a Director, Clinical QA (GCP) to join a biotech organisation. This role is on a permanent basis and is located in the Bay Area.Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance. Responsibilities:Monitor the CQA Systems, which involves leading improvement...
-
Quality Assurance Manager
2 weeks ago
San Francisco, United States Kimmel & Associates Full timeAbout the Company: A prominent construction firm known for their integrity, innovation, and commitment to quality, whose team-oriented environment fosters continuous learning and a strong work-life balance is currently seeking a Quality Assurance Manager. Our client specializes in various construction projects, with a focus on safety and excellence.About the...
-
Quality Assurance Manager
3 weeks ago
San Francisco, United States Shaw Bakers Full timeAbout Shaw Bakers At Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggressive, fast-growing company with a full pipeline of exciting new projects,...
-
Quality Assurance Manager
3 weeks ago
San Francisco, United States Kimmel Associates Full timeAbout the Company: A prominent construction firm known for their integrity, innovation, and commitment to quality, whose team-oriented environment fosters continuous learning and a strong work-life balance is currently seeking a Quality Assurance Manager. Our client specializes in various construction projects, with a focus on safety and excellence. About...
-
quality assurance specialist
4 weeks ago
Naval Station Complex, San Diego, United States Department Of The Navy Full timeSummary This is a public notice flyer to notify interested applicants of anticipated vacancies. Applications will not be accepted through this flyer. Interested applicants must follow the directions in the "How to Apply" section of this flyer to be considered. There may or may not be actual vacancies filled from this flyer. Notice of Result letters will not...