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.