Director-Quality Assurance Jobs

Are you passionate about making the world better? Are you looking for an organization that aligns with your values?

MRIGlobal solves challenging problems through science, engineering, and program management. We are an independent scientific research organization dedicated to benefiting society and fostering a safe, healthy, and sustainable environment.

When you embark on a career with MRIGlobal, you are joining a crew of world-class talent and problem solvers. Established in 1944, MRIGlobal is headquartered in Kansas City, MO, working in several states including Virginia and Maryland.

Basic Function / Nature and Scope

The Director of Quality Assurance (QA) is responsible for the effective design and implementation of the organization’s Quality Management System, to include leading a team of Quality Assurance professionals in ensuring services, processes, and facilities follow the organization's Quality Assurance standards, international standards, government regulations, and client requirements.

The Director of Quality Assurance reports to the Vice President of Business Operations. The Director has direct administrative and leadership responsibility for all Quality Assurance staff across multiple facilities in Kansas City and on the East Coast.

This role is intended for a seasoned Quality Assurance professional, who can operate independently, build teams, drive change, and interact with executive leadership on a regular basis. The position plays an integral role in ensuring compliance activities and continuous improvement with applicable regulations or standards. The position works closely with stakeholders to support a wide variety of departments and regulatory areas. Requires understanding of external standards such as International Organization for Standardization (ISO), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Clinical Laboratory Improvement Amendments/College of American Pathologists (CLIA/CAP) standards.

Essential Functions

Quality Management System Oversight: Design, implement, and enhance QMS for compliance with regulations and requirements. Ensure continuous development of QA methods for processes, procedures, and records. Responsible for designing, improving, maintaining, monitoring, and ensuring compliance of quality management system including but not limited to QA plans, training, process and equipment validation, equipment calibration and maintenance, supplier qualification, deviation investigations and CAPA management.

Information Exchange and Compliance: Facilitate timely information exchange within QA, sharing best practices and risk assessments. Provide technical and compliance expertise to business units and teams. Monitor quality systems (deviations, investigations, CAPAs) for timely processing and root cause analysis.

Resource Management and Collaboration: Manage resources within the QA department, including budgeting and performance tracking. Collaborate with stakeholders, directors, and managers on project feasibility and scope. Collaborate with Business Development to provide input on proposals' quality assurance approach and budget.

Quality Assurance and Compliance: Ensure proper execution and documentation of inspections and audits. Review and audit protocols and study reports for compliance and accuracy. Host regulatory agency and client inspections and audits.

Employee Development and Communication: Implement quality-focused training programs for employees. Communicate quality standards, process changes, and progress to employees. Provide leadership and guidance for staff during task execution and career development.

Strategic Planning and Execution: Formulate strategic plans and lead short to mid-term execution. Drive operational direction of the department.

Operational Excellence: Incorporate quality aspects into organization-wide operational planning. Identify areas for improvement in research and support operations and implement solutions. Establishes quantitative measurements, techniques, and processes for measuring and delivering quality outcomes and driving organizational improvements. Maintains documentation and training records as required by regulatory guidelines and MRIGlobal procedures. Performs other duties, functions and projects as necessary or assigned.

Supervisory/Management Responsibility (if applicable)

• Approves the selection of all new hires for the Quality Assurance team. Works with VP of Business Operations in defining staffing needs, selection/assessment criteria, and hiring strategy for staff.
• Recommends training needs of staff to improve performance and assist in career advancement. Establishes and executes a formal training program to ensure professional development and staff engagement within the team.
• Evaluates Quality Assurance staff performance accurately and fairly. Communicates and discusses performance on a regular basis. Prepares performance appraisals.
• Leads and manages a 10+ person QAU staff across multiple facilities and labs in Kansas City, MO; Gaithersburg, MD; Arlington, VA; and Charlottesville, VA.
• Identifies key development needs for staff and works to mentor staff and provide appropriate training and assignments in core competency areas.

Success Factors

Demonstrates Self-Awareness

• Reflects on activities and impact on others. Proactively seeks feedback without being defensive. Is open to criticism and talking about shortcomings. Admits mistakes and gains insight from experiences. Knows strengths, weaknesses, opportunities, and limits.

Communicates Effectively

• Is effective in a variety of communication settings: one-on-one, small and large groups, or among diverse styles and position levels. Attentively listens to others. Adjusts to fit the audience and the message. Provides timely and helpful information to others across the organization. Encourages the open expression of diverse ideas and opinions.

Collaborates

• Works cooperatively with others across the organization to achieve shared objectives. Represents own interests while being fair to others and their areas. Partners with others to get work done. Credits others for their contributions and accomplishments. Gains trust and support of others.

Instills Trust

• Follows through on commitments. Is seen as direct and truthful. Keeps confidence. Practice what they preach. Shows consistency between words and actions.

Drives Results

• Has a strong bottom-line orientation. Persists in accomplishing objectives despite obstacles and setbacks. Has a track record of exceeding goals successfully. Pushes self and helps others achieve results.

Ensures Accountability

• Follows through on commitments and makes sure others do the same. Acts with a clear sense of ownership. Takes personal responsibility for decisions, actions, and failures. Establishes clear responsibilities and processes for monitoring work and measuring results. Designs feedback loops into work.

Nimble Learning

• Learn quickly when facing new situations. Experiments to find new solutions. Takes on the challenge of unfamiliar tasks. Extracts lessons learned from failures and mistakes.

Self-Development

• Shows personal commitment and takes action to continuously improve. Accepts assignments that broaden capabilities. Learns from new experiences, from others, and from structured learning. Makes the most of available development resources.

Technical Knowledge

• Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.

Minimum Qualifications

• 10 years’ relevant experience.
• Bachelor’s degree in chemistry, biology, or related field

Preferred Qualifications

• Implemented or operated a quality program with an internationally recognized Quality Management System (ISO 9001, ISO 17025, and/or ISO 13485 standards)
• Experience in FDA regulated manufacturing preferred.
• Experience: 10+ years/expert in at least three quality regulations (GxP, 21 CFR 58, 21 CFR 210/211, 21 CFR 600, 21 CFR 820, 40 CFR 160), FDA guidelines and other applicable regulatory guidance documents
• Ability to obtain and maintain a security clearance.
• Ability to travel as needed.
• Master’s degree in related field preferred.
• Ability to collaborate and advise on Quality Assurance matters within priority markets for new opportunities.

What We Offer

At MRIGlobal, we offer benefits and perks that make your life even better.

Your Well-Being: You can receive comprehensive coverage for you and your family, as well as support through our onsite gym or discounted memberships. Feel great with virtual coaching, no-cost counseling, onsite screenings, and chair massages (HQ). MRIGlobal has received multiple wellness recognitions.

A Bright Future: MRIGlobal offers award-winning employer retirement matches and no-cost financial education benefits. Get paid Parental Leave. Enjoy PTO and a flexible culture that encourages work-life integration.

Personal Development: At MRIGlobal, you will enjoy diverse work that will grow your skills set, along with a tuition reimbursement option to pay for higher education.

A Genuine Community: MRIGlobal is a special workplace. From our Chili Cook-offs, Pi Day, and charitable giving opportunities, our traditions strengthen our team spirit. Join our DEI celebrations and volunteer in initiatives that nurture future STEM generations.

To view all of MRIGlobal's current openings and to ensure that we receive your resume, visit our Career page.

EOE, including disability/vets. As an organization dedicated to scientific advancement, MRIGlobal invites and embraces diversity in our people. We value their unique backgrounds and perspectives in every aspect of our mission. We are committed to creating a safe, welcoming, and inclusive environment where everyone feels respected and represented, fostering a culture where all input is welcome. We adapt to change, challenge the status quo, and evolve through belonging, allyship, and mutual support.

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