Quality Assurance Manager

Job Title: 

Reports to:

FLSA Status:  

Location:

Manager, Quality Assurance (QA)

Contracts Counsel

Full-time

Washington DC / Flexible

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.

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