Program Manager, Clinical Quality Assurance
By Takeda Pharmaceutical At , Boston, Ma
Solid judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Perform additional GCP related activities upon request by CQA management
Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.
Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.
Associate Director, Clinical Quality Assurance (Remote)
By Takeda Pharmaceutical At , Boston, Ma $143,500 - $200,000 a year
Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Participate in due diligence activities and process improvement initiatives, as requested by management
Mentor and provide support to Manager level CQA personnel, as needed
Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial and medical device experience.

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