Associate Director Regulatory Compliance

Job Summary

Responsible for establishing and managing the Quality Assurance programs in support of the Manufacturing business. Serves as a member of the Quality 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 operational teams to assure regulatory compliance and consistency with Charles River policies and procedures.

This key role is based in our Ballina facility Co. Mayo and will be functional on-site in a full-time capacity. This role may also require occasional  domestic and international travel.

Essential duties and Responsibilities

• Establish and manage the Quality Assurance program in support of Charles River, ensuring compliance and harmonisation with Charles River policies and procedures.
• Develop and maintain all required SOP’s, documents, forms, and documentation required to support business operations.
• Communicate all identified compliance and quality risks to his/her supervisor.
• Develop quality assurance policies and procedures to ensure applicable regulatory requirements are fulfilled.
• Identify the need for, and assist in the development of, Corporate and Business Unit 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 receive 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 personnel in managing compliance systems and assuring the timely completion of: (1) review and approval of 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 personnel 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.

Essential duties and Responsibilities continued

• 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.
• 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 compliance with applicable regulatory requirements.
• Participate in Quality 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 and 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 authorise expenditures.
• Develop and oversee the implementation of departmental training programs, including orientation.
• 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.

Qualifications, Requirements and Competencies

• Education: Bachelor’s degree (B.A. /B.S.) or equivalent. Advanced degree in biological sciences, pharmaceutical sciences, or computer sciences preferred.
• Experience: Seasoned and related experience in the GMP pharmaceutical and/or biotechnology-based industry.
• Leadership: Proven experience in leading teams implementing practices that improve efficiency.
• Demonstrates strong leadership ability, communication, and facilitation skills with both internal Charles River and external client personnel.
• 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 and creating new programs and processes.
• Experience with direct management of QA audits and inspections as well as interfacing with clients and 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.
• Strong knowledge of computerised system compliance, validation, and data integrity requirements.
• Skilled in process optimisation and continuous improvement.