Quality Assurance Manager

Job Title:

Reports to:

FLSA Status:

Location:

Manager, Quality Assurance (QA)

Contracts Counsel

Full-time

Washington DC / Flexible

Education Requirements

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

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.

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

Domestic and international travel: 10 to 20%

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