Quality / Regulatory Compliance Manager

Job Summary

We are seeking an experienced Quality/Regulatory Compliance Manager for our Biologics Division located in Ballina, Co. Mayo, Ireland.  

Reporting to the Senior Director, Regulatory Compliance, this role shall be responsible for managing the GMP Quality Assurance program to assure compliance with regulatory requirements and minimize any business interruption.  With 12 direct reports, this role shall also assist Regulatory Affairs and Compliance management in implementing the Charles River Compliance Program. Identify and recommend improvements in the Charles River Compliance Program and work with the site management team to assure regulatory compliance and consistency with Charles River policies and procedures.

• 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.
• Assist in the development and presentation of regulatory training for Quality Assurance and operations staff.
• 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; (5) review/approval of SOPs; (6) approval of Change 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.
• Meet with operations personnel to explain audit findings, resolve conflicts, and consult on corrective and preventative actions. 
• Interface with Regulatory Agencies during inspections. 
• 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.
• Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such 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.
• Perform general auditing duties for compliance with quality standards.
• Prepare written reports on audit and inspection activities.
• Review SOPs.
• Communicate all identified compliance and quality risks to his/her supervisor.
• Assist with Vendor Assessment, client audits and subcontractor audits.
• 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.

Profile and Requirements

The following are minimum requirements related to the Quality/Regulatory Compliance Manager position. 

• BSc. in a relevant Science discipline.
• 5-10 years’ experience of working within a GMP environment with at least 5 of those in a Manager/Supervisor role.
• Previous experience acting as host of client and regulatory inspections quality is essential especially dealing with regulatory bodies such as HPRA & FDA.
• Meticulous attention to detail and high level of accuracy.
• Proven track record of leading and motivating a team.
• Good working knowledge of pertinent regulations.
• Demonstrates strong leadership ability, communication, and facilitation skills.
• Excellent interpersonal & communication skills both written and verbal.   
• Excellent IT Skills – MS Word, Excel, PowerPoint.