Quality / Regulatory Compliance Manager (Ballina, IE, F26D786)

Charles River Laboratories

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

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.

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

 

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

 

 

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