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
Lead, Gvp Quality Assurance
By Amylyx Pharmaceuticals At Cambridge, MA, United States
Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
Lead Quality Audit Management for internal and external GVP audits and other GxP areas as needed
8+ years GVP quality or compliance related discipline or equivalent quality management activities
At least 8 years pharmaceutical or biotechnological drug development experience
Bachelor’s degree or equivalent professional experience in nursing, pharmacy, medical technology discipline
Working knowledge of international GxP guidelines (ICH) and directives, international regulatory standards, including USA (FDA), EU (EMA), UK (MHRA), Japan (PMDA)
Quality Assurance Lead Jobs
By VHL Technologies Inc At North Andover, MA, United States
QA with 8+ years of experience in Software Quality Assurance (QA)
Manage and supervise a team for end-to-end Testing/QA activities.
Should have some experience in SQL Scripting
Experience in effectively defining the process guidelines within the team, implementing Agile methodologies.
we have a new job opening below. please let me know if you are interested.
North Andover, MA-Onsite from day one

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