-
Quality Assurance
2 weeks ago
ManTech International Corporation Washington, United StatesSecure our Nation, Ignite your FutureBecome an integral part of a diverse team while working at an Industry Leading Organization, where our employees come first. At ManTech, you'll help protect our national security while working on innovative projects that offer opportunities fo ...
-
Quality Assurance Specialist
2 weeks ago
Cambrex Washington, United StatesInformazioni sulla location: · Nello stabilimento di Paullo siamo in grado di sviluppare e produrre Principi Attivi Farmaceutici (API) generici e di marca e intermedi avanzati su scala commerciale. · La nostra gamma di prodotti comprende oltre 80 API generici prodotti secondo g ...
-
Quality Assurance Manager
2 days ago
VetJobs Washington, United StatesJob Description · To apply, please visit AFM's career center: Quality Assurance Manager · Job Summary: · The Quality Assurance Manger oversees the Quality Control Program and enforces adherence to the ISO standards and procedures. Assigned to the development, administration, a ...
-
Quality Assurance Auditor
2 weeks ago
Angarai Intl Washington, United StatesANGARAI · - Project Management firm based out of College Park, MD. · ANGARAI · is a professional management firm that is driven by excellence. We provide ample opportunities for growth in a challenging, yet closely-knit atmosphere. Our key focus is on providing holistic soluti ...
-
Quality Assurance Manager
4 weeks ago
KBEC Group Inc. Washington, United StatesJob Description · Job Description Salary: $30-$35 hourly rate · JOB DESCRIPTION · Quality Assurance Manager Job Description (1 Part-Time) - Youth Temporary Housing Program · KBEC Group is seeking a driven and enthusiastic Quality Assurance Manager. The QA Manager will be respo ...
-
Quality Assurance Technician
1 week ago
Aerovel Corporation Washington, United StatesAerovel is seeking an experienced Quality Assurance Technician to join our team on-site in Bingen, WA developing and manufacturing the next generation of long-range robotic aircraft. Aerovel is led by the aeronautical veterans who invented and developed the Group 2 small tactical ...
-
quality assurance specialist
1 week ago
Bureau of Engraving and Printing Washington, United StatesSummary · This position is located at Bureau of Engraving and Printing, within the Office of Quality Engineering and Management. As a QUALITY ASSURANCE SPECIALIST (QUALITY PROGRAM MANAGER, you will be expected to facilitate continued growth in OQEM by leading programs in functio ...
-
quality assurance specialist
2 weeks ago
Bureau of Engraving and Printing Washington, United StatesSummaryThis position is located at Bureau of Engraving and Printing, within the Office of Quality Engineering and Management. As a QUALITY ASSURANCE SPECIALIST (QUALITY PROGRAM MANAGER, you will be expected to facilitate continued growth in OQEM by leading programs in functional ...
-
Quality Assurance
3 weeks ago
Action Facilities Management Washington, United StatesJob Summary: · The Quality Assurance Manger oversees the Quality Control Program and enforces adherence to the ISO standards and procedures.Assigned to the development, administration, and daily functions of the quality control program, this position shall be fully trained in the ...
-
Quality Assurance
2 weeks ago
ManTech International Corporation Washington, United StatesSecure our Nation, Ignite your FutureBecome an integral part of a diverse team while working at an Industry Leading Organization, where our employees come first. At ManTech, you'll help protect our national security while working on innovative projects that offer opportunities fo ...
-
Quality Assurance Supervisor
1 week ago
US Government Other Agencies and Independent Organizations Washington, United StatesSummary · The Quality Assurance Supervisor position is located in the Landlord and Tenant Branch of the Civil Division, in the Superior Court of the District of Columbia. The position provides management, oversight, and quality review of branch functions and employee work, in com ...
-
Quality Assurance Coordinator
4 weeks ago
Balfour Beatty plc Washington, United StatesAs an industry leader Balfour Beattyoffers employees a comprehensive benefits package with competitivesalaries and more including:Medical, Dental, Vision and Life InsuranceHealth Savings Account401(k) with company matchFlexible Spending Accounts (Dependent & Medical Reimbursement ...
-
Quality Assurance
2 weeks ago
Selkirk Pharma Washington, United StatesSelkirk Pharma is seeking an experienced, industry tenured professional to be our next Quality Assurance (QA) Operations Manager. This leadership role is primarily responsible for adherence to defined timelines as it relates to the development, support and executions of programs/ ...
-
Senior Quality Assurance
3 weeks ago
Ampcus Washington, United StatesSkills Required: · • t least 7 years' experience in System testing, both front end and backend · • bility to work independently in an Agile setting · • Experience in Team Foundation Server · • Experience in Azure DevOps · • bility to develop user support documentation and tr ...
-
Quality Assurance
3 days ago
ManTech International Corporation Washington, United States Full timeSecure our Nation, Ignite your Future · Become an integral part of a diverse team while working at an Industry Leading Organization, where our employees come first. At ManTech, you'll help protect our national security while working on innovative projects that offer opportunities ...
-
Quality Assurance
3 weeks ago
ManTech International Corporation Washington, United States Full timeSecure our Nation, Ignite your Future · Become an integral part of a diverse team while working at an Industry Leading Organization, where our employees come first. At ManTech, you'll help protect our national security while working on innovative projects that offer opportunities ...
-
Quality Assurance and Improvement Specialist
2 weeks ago
MBI Health Services Washington, United StatesJob DescriptionThe Quality Assurance and Improvement (QA/QI) Specialist is responsible for conducting thorough quality assurance audits, analyze data related to consumer charts, consumer care, consumer service provision in accordance with Federal, State and local government polic ...
-
Quality Assurance/Test Engineer
3 weeks ago
General Dynamics Information Technology Washington, United StatesQuality Assurance/Test Engineer page is loaded · Quality Assurance/Test Engineer · Apply · locations · USA DC Washington · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · RQ173849 · Type of Requisition: · Pipeline · Clearance Level Must Cu ...
-
Quality Assurance Senior Associate
3 weeks ago
Washington Metro Washington, United StatesQuality Assurance Senior Associate · Job ID: · 240072 · Location: · DC/MD/VA Metro Locations · Full/Part Time: · Full-Time · Posting Open-Close · 03/01/2024 · 05/29/2024 · Union · 002 · Regular/Temporary: · Regular · Job Description · Minimum Qualifications · Education · Bachelor ...
-
Quality Assurance Information Coordinator
4 weeks ago
Children's National Health System Washington, United StatesJob Description - Quality Assurance Information Coordinator (Pharmacy FT) · Job Description · Quality Assurance Information Coordinator (Pharmacy) · - · ( · 230003FT · ) · Description · Under the direction of the Chief of Pharmacy, Director of Pharmacy Operations, and the Ma ...
Sr. Director Quality Assurance - Washington, United States - SystImmune Inc.
Description
Sr. Director Quality Assurance - Good Clinical Practice (GCP)This position requires a hybrid working model, with expectations of being in office 2-3 days a week at either the headquarters of Redmond, WA or an office in central New Jersey, which location is being determined.
Company Overview:
SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered in Redmond, WA. Our mission is to revolutionize cancer treatment by developing breakthrough-therapeutic multi-specific antibodies and ADCs.
With eight assets in ongoing clinical trials and a robust preclinical pipeline, we are committed to advancing innovative therapies from discovery through IND-enabling stages.
Job Summary:
We are seeking a meticulous and detail-oriented Quality Assurance candidate with expertise in Good Clinical Practice (GCP) to join our team.
The ideal person will be responsible for ensuring that all clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies related to GCP.
This role plays a crucial part in maintaining the integrity, reliability, and ethical standards of our clinical research endeavors.Key Responsibilities:
Compliance Oversight:
Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws.
Documentation Review:
Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
Audits and Inspections:
Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
Training and Education:
Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders
Risk Management:
Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively.
Maintain and enhance SystImmune's QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
Vendor Oversight:
Evaluate and monitor the performance of third-party vendors, including contract research organizations (CROs) to ensure compliance with GCP requirements.
Continuous Improvement:
Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.
Qualifications:
Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
SME in GCP guidelines, ICH-GCP, FDA regulations, and other relevant regulatory requirements.
Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
Detail-oriented mindset with a proactive approach to problem-solving and decision-making.
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
Competitive salary and benefits package.
Opportunities for professional development and career advancement.
Work in a dynamic and collaborative environment at the forefront of clinical research.
Contribute to meaningful projects that have the potential to improve patient outcomes and advance medical science.
The hiring pay range for this position is $240,000 - $280,000 per year based on skills, education, and experience relevant to the role.
SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
#J-18808-Ljbffr