• Director, Quality Management Office

    Location US-MD-Silver Spring
    Job ID
    2018-1762
    Category
    Other
    Type
    Regular Full-Time
  • Overview

    Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

     

    The Director, Quality Management Office (QMO) will work with the Chief Operating Officer to establish and achieve the overall quality goals and initiatives of the organization and maintain the Corporate Quality Management Plan. This position will lead development of any corporate and operating group Standard Operating Procedures (SOP) and ensure maintenance of existing procedures. The Director, QMO will lead and assist the management team in the implementation and delivery of Social & Scientific Systems corporate commitment to quality systems. This individual will promote the QMO to current and prospective sponsors, lead efforts and develop documentation to implement project quality management plans and maintain corporate quality compliance with regulatory agencies, as well as industry and government sponsors.

    Responsibilities

    • Manage the day to day activities of the Quality Management Office, maintain the Corporate Quality Management Plan, and assist in development of project and study specific Quality Management Plans
    • Oversee development, stakeholder review and approval processes for Standard Operating Procedures governing FDA regulated tasks and SOP deviations.
    • Be responsible for all activities involving quality assurance and compliance of internal operations with applicable regulatory requirements, Good Clinical Practice (ICHGCP), company SOPs and policies, QA validation activities and compliance training
    • Prepare for, conduct/facilitate and respond to sponsor and regulatory agency audits / prepare for and conduct internal process and project audits / identify needed actions because of internal or external audits.
    • Participate in establishing, maintaining and updating standards and ensuring compliance of standards with applicable regulatory requirements including Quality by Design (ICH E6 R2)
    • Review documentation to ensure that controlled documents are followed, standards of quality are maintained, and documentation is complete
    • Development of quality sections of proposals and participate/ host client capability assessments and audits
    • Ensure procedural training is complete, documented and in compliance and conduct new hire training
    • Oversee quality assurance planning for study related activities
    • Perform review of quality metrics, CAPA findings and business process improvement opportunities, and recommend effective solutions to enhance quality and efficiency, establishing QA processes and standards and compliance related training
    • Develop and approve software validation documentation and ensure QA review of executed validation materials
    • Provide consultative advice in related areas (non-compliance, Human Subject Protection, PHI/PII disclosures, GCP, QA, standards, escalated issues and unanticipated problem) internally and to sponsors, as needed
    • Manage the Corporate vault within the company electronic trial master file system.

    Qualifications

     

    • Bachelor’s degree and at least 10 years progressively responsible experience with quality management of FDA-regulated clinical trials. Broad experience with corporate-level quality management systems is a plus.
    • Demonstrated knowledge of the Code of Federal Regulations and ICH GCP governing clinical research.
    • At least 5 years of demonstrated supervisory responsibilities and department management experience in previous positions.
    • Excellent verbal and written communication skills, including business and technical writing, and a solid command of Standard English grammar and mechanics.
    • Excellent interpersonal, client relations and regulatory inspection skills. The selected candidate will be able to coach and advise staff on maintaining compliance with quality standards, and assist with preparation of deviation reports and CAPA plans in a helpful, non-judgmental manner.
    • Demonstrated decision-making abilities and problem-solving skills; exhibit competency to make higher-level decisions that may have a consequential effect on a project and/or SSS
    • Excellent organizational and time management skills, with strong sense of urgency and attention to detail.
    • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint;
    • Proficiency and experience with project management tracking systems is a plus for Quality by Design and RBM project initiatives.

     

    SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

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