Our client, located in Somerset, NJ, is looking to add a Quality Assurance Manager to their team. The Quality Assurance Manager will be responsible for overseeing the development and testing of clinical software applications, training programs, and internal and external audits.
This is full-time, direct hire, in person position.
Salary: $70,000 - $75,000/year dependent on experience.
Responsibilities:
Develop, implement, and maintain a robust quality management system including standard operating procedures, plans, or policies. Drive continuous improvement in quality processes and systems.
Develop validation plans and protocols in accordance with regulatory requirements and industry best practices. Oversee validation activities and maintain thorough and accurate validation documentation, ensuring traceability from requirements to final product release.
Develop and implement training on QA processes, regulatory requirements, and validation procedures. Evaluate training programs.
Identify and analyze non-compliance, potential risk, and conduct root cause. Develop, implement, and monitor corrective and preventative action plans and verify their effectiveness.
Perform internal and external audits to ensure compliance with good clinical practice, standard operating procedures, and regulatory requirements.
Stay updated on regulatory changes and industry standards related to clinical software and inform the team accordingly.
Qualifications:
Bachelor's degree.
3 years of work experience in quality assurance within clinical software development and validation or in clinical trial software application support.
Strong understanding of software development lifecycle, software testing methodologies, and validation principles.
In-depth knowledge of GCP, regulatory requirements, and clinical trial processes.
Familiarity with regulatory requirements and standards including FDA 21 CFR Part 11, GCP, and ISO 14155.
Ability to work both independently and collaboratively in a fast-paced, team environment.
Ability to prioritize workload while meeting multiple requests and deadlines in a consistent and timely manner.
Excellent organizational skills and attention to detail.
Excellent written and verbal communication skills.
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