Quality Manager

Req ID:  179636
Location: 

Ballina, IE, F26D786

For 70 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 Manager for our Biologics Division located in Ballina, Co. Mayo, Ireland.  

Profile and Requirements

 

Reporting to the CVP Global Biologics QA, this role shall be responsible for managing the GMP Quality Assurance program to assure compliance with regulatory requirements and minimize any business interruption.  With 9 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.
•   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.
•    Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
•    Perform duties in accordance with GLP, GMP or GCP according to the requirements of the assigned task.

 

Requirements: 


•    BSc. in a relevant Science discipline.
•    5-10 years’ experience of working within a GLP/GMP environment with at least 5 of those in a Manager/Supervisor role.
•    Previous quality auditing experience 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.
•    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 14,000 employees within 80 facilities in 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. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

 

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 ~85% of the drugs approved by the FDA in 2018.