Quality Assurance Manager

Education Requirements

• Bachelor’s degree in a relevant scientific discipline
• MS/MPH preferred

 

Work Experience

• At least 5-7 years of QA, clinical trial and regulatory standards experience

 

Job Duties and Responsibilities

• Develop an agile QMS that aligns with I-ACT for Children’s Learning Management System (LMS)
• Perform ongoing gap analyses as I-ACT for Children expands
• Draft, revise, track, and update policies and procedures for regulated business operations
• Ensure compliance with I-ACT for Children's procedures and regulatory requirements
• Point person to identify and communicate GxP quality and compliance risks and participate in determination of appropriate plan for resolving the issues and addressing risks
• Provide guidance, interpretation and information on GCP regulations, standards and quality systems.
• Liaise with the auditing function of all I-ACT for Children’s pharma members as well as other clients, vendors and CROs to ensure proper QA oversight and representation
• Lead the completion of audit function questionnaires, assessments and hosting of sponsor, CRO, and/or regulatory authority inspections. Develop annual audit plans that align with business goals for continued quality and compliance
• Manage and conduct internal, external and vendor/supplier audits and program(s)
• Develop training programs and partner in strategic initiatives
• Manage LMS and ensure compliance with all annual training requirements
• Other duties and responsibilities may be assigned

Knowledge/Skill/Abilities:

• Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement
• Knowledge of domestic and international regulatory requirements
• Understanding of requirements/documentation of system validation
• Works well independently and in a team-oriented, collaborative environment
• Proficiency with Microsoft Office, including Outlook, Excel and PowerPoint
• Strong oral and written communication skills; ability to actively maintain good professional relationships, effectively present information and facilitate group discussion
• Good problem-solving, analytical, and organizational skills
• Self-motivation and the ability to work in a fast-paced environment while handling multiple demands and shifting priorities with flexibility and willingness to adapt in a changing environment.

Supervisory Responsibility

This position may supervise 1-2 direct reports and/or
contract personnel

 

Travel

Domestic and international travel: 10 to 20%

 

Salary & Benefits

Commensurate with experience and aligned with US benchmarked
ranges for a research-based non-profit of this size and complexity.