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Associate Director Quality Assurance

Company: Charles River Laboratories
Location: Shrewsbury
Posted on: March 16, 2023

Job Description:

Basic Summary Responsible for managing the Quality Assurance program at a Charles River operation and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the Charles River Compliance Program and coordinates with peers to promote consistency in quality assurance operations, regulatory interpretation, and processes. Works with the site management team to assure regulatory compliance and consistency with Charles River policies and procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Communicate all identified compliance and quality risks to his/her supervisor.
  • Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled
  • Identify the need for, and assist in the development of, Corporate Quality and Compliance Policies.
  • Manage Quality Assurance operational groups to assure inspections and audits are accurate, thorough, timely, and provide the correct interpretation of regulatory requirements and corporate policies.
  • Assure staff receives appropriate regulatory and management training, and mentoring to enable the execution of regulatory and management responsibilities.
  • Assume a lead role in the development and presentation of regulatory training for Quality Assurance and operations staff.
  • Monitor the effectiveness of subordinate managers in managing compliance systems and assuring the timely completion of:
  • (1) audits of regulatory records and reports;
  • (2) inspections of facilities and equipment;
  • (3) investigations,
  • (4) audits of methods, practices, and controls; and
  • (5) Regulatory Affairs and Compliance projects and programs.
  • Identify and resolve any scheduling conflicts and program priorities to assure timelines are fulfilled.
  • Monitor the effectiveness of subordinate Quality Assurance managers in reviewing Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
  • Identify and resolve inconsistencies between Quality Assurance audit teams should they occur.
  • Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
  • Serves as a liaison with operations managers to identify regulatory deficiencies, explain audit findings, resolve conflicts, and consult on corrective and preventative actions.
  • Assemble, evaluate, and report group metrics measuring compliance and quality key performance indicators.
  • Represent the corporation during regulatory and client inspections/audits
  • Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such audits.
  • Lead the preparation of regulatory and client audit responses and corrective action commitments.
  • Monitor site/operation corrective actions commitments and communicate "at risk" commitments to management with recommendations for their timely resolution. MINIMUM QUALIFICATIONS
    • Identify practices, methods, and processes for improvement and assist other operations on related compliance issues.
    • Assure vendors and suppliers identified/designated by Charles River are assessed for the compliance with applicable regulatory requirements.
    • Participate in Regulatory Affairs and Compliance projects and programs.
    • Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings, intranet communications, and relevant strategic planning sessions.
    • Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
    • Direct activities of assigned group(s) to ensure optimum performance of the group/function.
    • Responsible for personnel management activities such as:
    • scheduling,
    • personnel actions (hiring, promotions, transfers, etc.),
    • training and development,
    • providing regular direction and feedback on performance,
    • disciplinary actions and preparing,
    • delivering annual performance and salary reviews.
    • Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
    • Integrate activities with those of other major organizational units (e.g. segments, departments, functions).
    • Develop and recommend departmental budget and authorize expenditures.
    • Develop and oversee the implementation of departmental training programs, including orientation.
    • Support the policy of equal employment opportunity through affirmative action in personnel actions.
    • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
    • Communicate all identified compliance and quality risks to his/her supervisor.
    • Performs all other related duties as assigned.
      • Bachelor's degree (B.A. /B.S.) or equivalent. Advanced degree in biological sciences, pharmaceutical sciences, or computer sciences preferred.
      • Seven to Ten years related experience in the pharmaceutical and/or biotechnology based industry.
      • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
      • Strong experience and direct responsibility for management of Quality Assurance programs.
      • Experience with direct management of QA audits and inspections as well as interfacing with regulatory agencies and preparing/reviewing responses to any inspectional findings.
      • Strong knowledge of pertinent national and international regulations pertaining to the pharmaceutical and biotechnology industries.
      • Demonstrates strong leadership ability, communication, and facilitation skills.
      • Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
      • Must regularly communicate with employees/customers; must be able to exchange accurate information.
      • Must occasionally move about inside the office to access file cabinets, office machinery, etc.
      • Requires regular domestic and international travel.

Keywords: Charles River Laboratories, Worcester , Associate Director Quality Assurance, Executive , Shrewsbury, Massachusetts

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