ATCC

  • Director Regulatory Affairs/Quality Assurance (RA/QA)

    Job Locations US-VA-Manassas
    Job ID
    2018-2043
    Department
    Executive CEO Office
    Posted Date
    5/1/2018
  • Overview

    Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.   


    The Director of Regulatory Affairs & Quality Assurance (RA/QA) will proactively develop, lead and drive the execution of ATCC’s global regulatory and quality assurance strategy. The position is will be responsible for regulatory affairs, quality assurance, and compliance activities. The Director QA/RA will establish and implement policies, procedures, specifications and forms for the Quality Management System (QMS) and direct RA/QA staff.

     

    This position must work and think independently; duties of this position are to be completed under minimal to no guidance. Decision making is a key component of this position, and decisions have a significant impact on the overall success of the Organization. Discretion in handling assigned responsibilities, including the ability to resolve problems and exercise good judgment while maintaining confidentiality is expected from all ATCC employees.  Functions are to be completed in a timely manner with acceptable quality.

    Responsibilities

    1. Define and execute the RA/QA activities to support business unit and corporate strategy; and Responsible for keeping the Executive Leadership Team informed of regulatory status and significant regulatory issues; Manages the function; and Manages yearly target budget and capital plan
    2. Provides counsel, training, and interpretation of the FDA’s and other regulatory authorities’ feedback, policies, and guidelines
    3. Establish, manage and maintain compliance with FDA QSR, including establishment registration, Quality Assurance including, but not limited to, Product Release, CAPA, NCMR, Complaints, Supplier Qualification, Document Control, Training, Internal/External Audits; Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies
    4. Establish, manage and maintain compliance with other global regulatory standards, including but not limited to CE Marks, ISO13485 and 17025.
    5. Develop and maintain external relationships with key opinion leaders, and regulatory officials
    6. Act as the point of contact for all regulatory communication in the company
    7. Responsible for defining the Company’s quality goals each year
    8. Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
    9. Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GLP quality systems and management
    10. Collaborates cross-functionally with internal departments on strategy and implementation of quality principles and regulation requirements
    11. Perform other duties as assigned.

    Qualifications

    Education and Experience:

    • A Bachelor’s of Science Degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) with fifteen (15) + years’ experience in Quality Assurance and Regulatory Affairs within the biotechnology industry.
    • At least five (5) years’ experience in management of Regulatory Affairs/Quality Assurance at a biorepository, medical device or pharmaceutical company.

    Knowledge, Skills and Abilities:

    • Comprehensive knowledge and understanding of worldwide regulatory standards.
    • Extensive experience with development, implementation and maintenance of successful regulatory standards compliance programs.
    • Strong leadership and organizational development skills.
    • Strong commitment to excellence and a passion for cultivating strong client relationships and championing business growth. 
    • Self-starter, motivated and takes initiative; strong interpersonal and problem-solving skills; able to work collaboratively with all levels of staff to resolve problems and external partners to maximize performance, creativity, problem solving and results.
    • Seek, learn, and apply new skills/knowledge to perform job responsibilities.
    • Attentive to detail with a high level of accuracy; exercise sound judgment.
    • Resourceful, diplomatic and professional; deliver outstanding customer service while managing relationships; a can-do attitude and work style that supports teamwork, collaboration and positive relationships.
    • Adaptable; be able to shift priorities and focus as departmental and/or business demands change including, but not limited to early/late hours and/or weekend hours.
    • Strong analytical skills and organized; completes tasks ahead of schedule.
    • Excellent written and verbal communication skills, including excellent listening skills and presentation skills to communicate clearly, concisely and effectively.
    • Position-relevant computer experience including Microsoft Office.
    • Follow all company safety practices, Standard Operating Procedures (SOP’s) and policies.

    ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

     

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