Quality / Regulatory Compliance Manager

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

Do you have expertise in working to GMP standards, within a Quality Assurance function? 

 

Are you a motivated people leader, with the desire to play a key role in career development? 

 

The Role 
We have an exciting opportunity within our Biologics Division located in Ballina, Co. Mayo, Ireland for a Quality/Regulatory Compliance Manager to join the team on a permanent, full-time basis. Reporting to the Senior Director, Regulatory Compliance, you’ll be responsible for a group of 12 direct reports with oversight of the GMP Quality Assurance program to assure compliance with regulatory requirements and minimize any business interruption. 

You will 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.

This is a fantastic role for someone who has forged their career within Quality Assurance and Compliance who is looking to take the next step and join a fast-paced, global organisation dedicated to improving the lives of their patients.

 

Responsibilities

In this role, you'll be expected to:
•    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. 

What we offer you:
•    A very comprehensive benefits package from day one, including a  pension contribution, private medical for you (and can add family members), private dental care, critical illness cover, bonus and more!
•    Access to grea