Responsible for managing the Quality Assurance program component at a Charles River operation. Assists Regulatory Affairs and Compliance management in implementing the Charles River Compliance Program. 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.
•Manage direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
•Assure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities.
•Schedule resources to manage compliance systems and assure 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.
•Review and endorse Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
•Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
•Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management.
•Represent the corporation during regulatory and client inspections/audits.
•Coordinate the preparation of regulatory and client audit responses and corrective action commitments.
•Track corrective actions and apprise management of their status.
•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.
•Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
•Manage 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 and delivering annual performance and salary reviews.
•Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
•Assist in the development and recommendation of 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].
•Performs all other related duties as assigned
•Education: Bachelor’s degree (B.A./B.S.) or equivalent
•Experience: Minimum of five (5) years 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.
•Experience in supervision quality assurance, quality control, and/or regulatory affairs.
•Experience with assisting or managing QA audits and inspections as well as interfacing with regulatory agencies.
•Good working knowledge of pertinent regulations and site SOPs.
•Demonstrates strong leadership ability, communication, and facilitation skills.