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Associate Clinical Quality Assurance (QA) Director

Company: MacroGenics, Inc.
Location: Rockville
Posted on: September 14, 2023

Job Description:

Associate Clinical Quality Assurance (QA) Director MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of -350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.Our products and platforms have attracted multiple partnerships with leading pharmaceutical -and biotechnology -companies around the globe. -MacroGenics is a bold, highly engaged, and diverse team driven by a passion for improving the lives of patients through innovative science. We are committed to an inclusive workplace built on trust and respect. We value and nurture strong connections with one another and foster collaborative relationships. We empower our people and drive personal accountability. We encourage curiosity and -embrace our entrepreneurial spirit. We celebrate our successes and create a learning environment where all employees can thrive! -Summary of PositionAs Associate Director, Clinical Quality Assurance you will apply your established knowledge of GCP guidance and regulations to lead Clinical Quality Assurance activities for assigned clinical development programs. Also responsible for overseeing and executing the assigned audit plans and strategies on assigned programs, and ensuring GCP compliance by working proactively and cross functionally with Clinical Operations partners.Key Responsibilities:

  • Oversee the development, implementation, and continuous improvement of Clinical Quality Management System, ensuring compliance with industry standards, regulations, and best practices on assigned audit plans.
  • Manages and/or conducts the planning, execution and resolution of risk-based investigator site, vendor and internal system audits of MacroGenics processes.
  • Evaluates audit responses, as well as routinely monitors established quality and performance metrics to identify potential quality related trends or areas of regulatory risk. Makes recommendations for resolution and/or escalates, as appropriate to senior management.
  • Manages study level risk assessments to proactively identify and mitigate significant compliance risks.
  • Facilitates the development and maintenance of all processes, procedures, and systems relate to clinical trial activities for all Clinical Development functional areas to ensure compliance with applicable regulations and the MacroGenics quality system requirements. Identifies any areas of concern, develops proposals for action plans, and drives solutions where possible. Raises unresolved issues with Quality senior management if necessary.
  • Provides consultation regarding recently released health authority regulations or guidance, as well as topics of current regulatory emphasis to MacroGenics clinical study teams and/or relevant clinical functional areas. Viewed as an expert in this area.
  • Designs and conducts annual GCP training programs for Clinical Development personnel.
  • Performs other Clinical QA duties as assigned.QualificationsEducation & Credentials
    • Bachelor's degree. Life Sciences field of study preferred. Equivalent experience will be considered in lieu of a degree.Experience
      • Minimum of nine (9) years pharmaceutical/biotech clinical research or clinical operations experience
      • Minimum of five years of GCP auditing experience
      • Experienced in developing and providing GCP training to a wide range of audiences
      • Experience with international clinical trials Knowledge, Skills and Abilities
        • In-depth knowledge of FDA and ICH GCP regulations, guidelines and industry best practices.
        • Keen awareness of the practical application of these GCP regulations/guidelines.
        • Demonstrated ability to respond to inquiries from regulatory agencies.
        • Ability to effectively present information cross-functionally and to management.
        • Ability to write effective audit reports.
        • Strong knowledge of MS Word, Excel, PowerPoint & Outlook.
        • Excellent communication, analytical, and organizational skills.
        • Working knowledge of GLP, and/or GMP guidelines and regulations
        • Strong attention to detail
        • Must be able to manage competing priorities and meet deadlines.
        • Able to travel at least 50% of the time, both domestic and international.Supervisory -Responsibilities - -NoneStatementMacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service. -Equal Opportunity Employer/Veterans/DisabledWe do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.

Keywords: MacroGenics, Inc., Rockville , Associate Clinical Quality Assurance (QA) Director, Executive , Rockville, Maryland

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