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Manager QA Distribution
4 months ago
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
The Manager QA Distribution reports to the Director Quality Assurance. This role will be responsible for Quality warehouse operations for GMP materials. The role will be responsible for managing quality operations functions, raw material storage, distribution operations, supporting client and regulatory audits and drive continuous improvements opportunities. The Memphis site supports a CDMO cell therapy manufacturing site.
Oversees a wide variety of activities to ensure compliance with applicable regulatory requirements as it pertains to drug product storage and distribution operations. Establishes and maintains procedures and processes to ensure compliance with the US and global current Good Distribution Practice (GDP) and current Good Manufacturing Practice (GMP). Lead, develop and mentor a Quality Assurance team Work collaboratively with the Biomanufacturing, Quality Systems, Quality Control, Project Management, Facilities, and Supply Chain units to meet company and client goals. Interfaces with and provides QA oversight of all raw material receipt, storage, and issuance. Develop and track Key Performance Indicators (KPI). Participates in developing Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met. Review shipping records and associated data relating to product distribution activities. Participates in the development & delivery of training programs. Support regulatory inspections and internal audit programs. Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Distribution. Conducts gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as company standards.
Job Qualifications
Bachelor’s Degree in life sciences or related field preferred Experience 5 - 8 years of experience within a GMP/ Good Distribution Practice (GDP) Environment preferred 5+ years of experience within professional level Quality Assurance/Operations, Compliance, Supply Chain/Materials Management preferred 3+ years in a supervisory or leadership role is preferred Experience supporting/hosting FDA and State Pharmacy Board inspections preferred Demonstrates proficiency in SAP.The pay range for this position is $98K - $125K. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 characterization, 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.
