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Clinical Quality Assurance Lead Jobs

Clinical Quality Assurance Professional - Remote
By W. L. Gore & Associates At , Flagstaff, 86001, Az
Support the Clinical vendor qualification, selection, and management process
Working knowledge of inspection management
Demonstrated project management and leadership skills
Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries
Minimum of 2 years experience in clinical and/or quality system compliance and auditing
Knowledge of Good Clinical Practices (GCP) and all applicable regulations
Director, Clinical Quality Assurance
By Arcus Biosciences At , Remote
Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), EU (EMA, MHRA), and ICH Guidelines.
Experience leading audits of GCP vendors and investigator sites.
A strong team player with great interpersonal and written communication skills
Support clinical study teams for assigned studies through attendance at study meetings, review of study documents, and consultation on GCP-related questions.
Identify and escalate significant compliance issues to Clinical QA and other relevant leadership, including the assessment of serious breaches.
Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.
Quality Assurance Lead (Est/Gene Therapy)
By Planet Pharma At Greater Boston, United States
You are proficient in project management
Manufacturing site qualification and onboarding
Maintain product quality oversight, creating consistency using CellPoint’s central site capabilities and data.
Experience in a ATMP manufacturing setting is preferred
Experience in a commercial GMP manufacturing setting is preferred
You have good interpersonal skills
Quality Assurance Lead Jobs
By Innovalus Technologies At Washington, DC, United States
Monitor and report on key quality metrics, trends, and issues to senior management and other stakeholders.
Manage the quality assurance budget, including the identification and management of resources to ensure effective execution of quality initiatives.
Bachelor's degree in a relevant field such as engineering, quality management, or a related discipline
Develop and maintain quality systems, policies, and procedures to ensure compliance with applicable regulatory requirements, industry standards, and customer expectations.
Manage a team of quality assurance professionals, providing guidance, training, and support as needed.
Participate in the review and approval of product and process changes to ensure compliance with quality standards and customer requirements.
Business Analyst Quality Assurance Lead
By Global Mobility Services At United States
Participate in requirement & design review sessions; evaluate requirements & design docs from a quality standpoint.
Understand business process, design and development activities in order to understand test requirements and facilitate test automation.
Coordinate with project managers, business analysts, business partners and developers throughout SDLC to promote quality
Actively participate sprint grooming/planning or requirement reviews, test execution and retrospectives or Lesson learned activities
Manage defects from creation to root cause
Experience with some languages to test: VB, C#, C++, Java, SQL, Soap, XML, other Web Service
Quality Assurance - Clinical Research
By ViTalent At Westfield, IN, United States
Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.
Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
Education, Experience, Competencies And Skills
Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
Ensure compliance with Sponsor Learning Curricula, corporate and/or GXP requirements.
Quality Assurance Lead Jobs
By Mastech Digital At Jacksonville, FL, United States
4 years of experience as a Team lead/manager
Experience with Structured Query Language (SQL) and relational database structures with knowledge of system integration
Bachelor's degree or equivalent experience in Engineering
7 years of Software Quality Assurance and testing experience working within an Agile environment using Agile methodologies
Experience with Test Automation and API/ Services Testing
Experience reporting testing results in a clear, detailed, and analytical style using fact-based metrics
Quality Assurance Lead Jobs
By GCS At Philadelphia, PA, United States

We are seeking a highly skilled and experienced QA Lead to join our telecommunications team. As a QA Lead, you will be responsible for leading the quality assurance efforts in the domain of set-top ...

Quality Assurance Lead Jobs
By Enexus Global Inc. At Dallas, TX, United States
• Experience with tools like JMeter RestAssured, etc
Location onsite - Alpharetta, GA/ Dallas, TX/New York , NY/ Chicago, IL
• Ability to create and maintain testing frameworks.
• Automation, Acceptance, Functional, Regression, Integration and Manual tests
• Performing data migration/conversion testing
• Implementing testing suites/harness within a cloud platform.
Quality Assurance Lead Jobs
By La Fabrica LLC At Garland, TX, United States

Responsibilities: As a Food Safety and Quality Assurance you will be responsible for ensuring the process are followed according to Food Safety Plan (HACCP). Verification activities in Food Safety ...

Quality Assurance Lead Jobs
By ChabezTech LLC At San Antonio, TX, United States
·Bachelor’s degree in Computer Science, Information Systems, or equivalent education or work experience.
·Build product definitions and leverage technical skills to determine solutions.
·Experience in Guidewire policy center testing
·Experience in test automation, frameworks, and testing tools
·Practical knowledge of working in an Agile environment.
·Experience with continuous delivery and infrastructure as code.
Quality Assurance Automation Lead
By Tekfynder At Secaucus, NJ, United States

QA Lead Onsite: Secaucus, NJ IBM/CIGNA Rate: $69.00/hr JD Automation Testing: QA Lead Selenium Cucumber ...

Quality Assurance Lead Jobs
By Cibo Vita At Totowa, NJ, United States
Knowledge of HACCP and food safety management systems is a plus.
Manage and execute product testing, shelf-life testing, and sensory testing.
Conduct audits of suppliers and internal facilities to ensure compliance with quality control requirements.
Minimum of 5 years of experience in quality assurance, quality control, or a related field in the food production industry.
Knowledge of FDA, USDA, GMP, and other quality and safety regulations.
Experience in SQF, Organic, kosher, RSPO, UTZ.
Senior Manager, Clinical Quality Assurance
By CRISPR Therapeutics At Boston, MA, United States
Demonstrated knowledge and/or prior experience in Quality Assurance
Ability to manage multiple studies/projects and to collaborate effectively in a dynamic, cross-functional matrix environment
BS/BA with 8 to 10 years of experience in pharmaceutical / biotech industry with experience in the GLP/GCLP environment
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP
Practical knowledge of GLP/GCLP related audits activities and business standards
Prior experience with nonclinical studies and CRO oversight
Quality Assurance Lead Jobs
By BioData Partners At United States
Ensure RC&QA management responsibilities, asindicatedin applicable controlled documents, are followed
Excellent organizational, time management and project management skills
Proficient with relevant software and experience with electronic quality management systems
Develop audit management plans and audit strategy with clients for ongoing clinical trials.
Escalate issues to managementin a timely mannerimplementingappropriate solutions, including preventative actions
Perform other duties, as assigned by management
Associate Director/Sr Manager Clinical Quality Assurance
By Meet At Pennsylvania, United States
Management of external vendors (CROs and CTLs)
Experience and ability to manage and start a QA department from scratch
Clinical Quality Senior Manager/Associate Director – Competitive Salary + Great Benefits + Hybrid
Proceeding to the Qualification and Validation of external vendors
To be successful in this role, your experience will need to include:
Conducting External and Internal GCP audits (US)
National Director Of Quality Assurance / Clinical
By HRA Senior Living At , Orlando, 32819, Fl
Applies technical skill and abilities for program design, development, implementation and evaluation
Utilizes management expertise to assist communities with resident care and nursing personnel issues
Collaborates with the senior management team members to achieve and maintain company goals
Experience using Microsoft Office and Outlook software. Basic typing skills required
Able to communicate effectively with all levels of management, associates, residents, family members, state regulatory agencies, hospitals, and outside contacts
Responsible to maintain current knowledge of state and local regulations
Clinical (Gcp) Quality Assurance Specialist
By a pharmaceutical company located in the Menlo Park, CA area At Menlo Park, CA, United States
Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs.
Minimum 5+ years’ experience in clinical stage pharmaceutical companies
Experience developing GCP processes for the best industry practices and training personnel
Participating in review and approval of clinical study documents and clinical SOPs / Guidance Documents
Managing study specific Clinical Study Audit Plans (CSAP) compliance for assigned program by using risk-based approach for the company’s clinical studies
Reviewing and approving investigational product (IP) temperature excursions to ensure release or rejection of IP in a timely manner
Appeals Clinical Services Operations Quality Assurance Specialist I
By Cambia Health Solutions At , Burlington, 98233, Wa $21.85 - $36.85 an hour
Generates reports as requested by management (i.e., accuracy, quality).
Intermediate computer skills (e.g. Microsoft Office, Outlook, Internet search) and experience with health care systems and documentation (EMR, billing and claims).
Strong analytical and problem-solving skills.
Demonstrated experience with writing, documentation, and editing.
One-time furniture and equipment allowance for employees working from home
Remote within WA, ID, OR, and UT
Quality Assurance Lead, Electronics Semiconductor Materials
By Merck KGaA Darmstadt Germany At , Dallas, Tx
Demonstrated working knowledge of ISO Quality Management Systems with experience in process and product audits.
Experience managing an effective Quality Management System.
Excellent time management and organizational skills with the ability to handle multiple activities, projects, and priorities.
Owner of site ISO 9001:2015 Quality Management System, supporting the overall quality program for the business. Leader of Management Review activities.
Manage tasks as required for QMS (Quality Management System) such as Control Plan, FMEA, MOC, Document Control, etc.
7+ years manufacturing, business, and quality experience in a fast-paced time sensitive environment.

Are you looking for an exciting opportunity to lead a team of quality assurance professionals and ensure the highest standards of clinical care? We are looking for a Clinical Quality Assurance Lead to join our team and help us ensure that our clinical services are of the highest quality. As the Clinical Quality Assurance Lead, you will be responsible for developing and implementing quality assurance processes, monitoring and evaluating clinical performance, and providing guidance and support to clinical staff. If you are an experienced leader with a passion for quality assurance, we want to hear from you!

Overview:

The Clinical Quality Assurance Lead is responsible for ensuring that clinical research activities are conducted in accordance with applicable regulations, standards, and guidelines. This role is responsible for developing, implementing, and maintaining quality assurance systems and processes to ensure compliance with applicable regulations and standards.

Detailed Job Description:

The Clinical Quality Assurance Lead is responsible for developing, implementing, and maintaining quality assurance systems and processes to ensure compliance with applicable regulations and standards. This role is responsible for conducting audits and inspections of clinical research activities, monitoring and evaluating clinical research data, and providing guidance and support to clinical research staff. The Clinical Quality Assurance Lead is also responsible for developing and maintaining quality assurance plans, policies, and procedures, and for providing training and education to clinical research staff.

What is Clinical Quality Assurance Lead Job Skills Required?

• Knowledge of applicable regulations, standards, and guidelines related to clinical research
• Ability to develop, implement, and maintain quality assurance systems and processes
• Ability to audit and inspect clinical research activities
• Ability to monitor and evaluate clinical research data
• Ability to provide guidance and support to clinical research staff
• Ability to develop and maintain quality assurance plans, policies, and procedures
• Ability to provide training and education to clinical research staff

What is Clinical Quality Assurance Lead Job Qualifications?

• Bachelor’s degree in a related field
• At least 5 years of experience in clinical research
• Knowledge of applicable regulations, standards, and guidelines related to clinical research
• Knowledge of quality assurance systems and processes
• Knowledge of auditing and inspection techniques
• Knowledge of clinical research data analysis

What is Clinical Quality Assurance Lead Job Knowledge?

• Knowledge of applicable regulations, standards, and guidelines related to clinical research
• Knowledge of quality assurance systems and processes
• Knowledge of auditing and inspection techniques
• Knowledge of clinical research data analysis
• Knowledge of quality assurance plans, policies, and procedures
• Knowledge of training and education techniques

What is Clinical Quality Assurance Lead Job Experience?

• At least 5 years of experience in clinical research
• Experience in developing, implementing, and maintaining quality assurance systems and processes
• Experience in auditing and inspecting clinical research activities
• Experience in monitoring and evaluating clinical research data
• Experience in developing and maintaining quality assurance plans, policies, and procedures
• Experience in providing training and education to clinical research staff

What is Clinical Quality Assurance Lead Job Responsibilities?

• Develop, implement, and maintain quality assurance systems and processes to ensure compliance with applicable regulations and standards
• Conduct audits and inspections of