Manager Quality Operations

Location

Memphis, TN | United States

Job description

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 Quality Operations reports to the Director Quality Assurance Operations. This role will be responsible for one of three functional areas within Quality Operations (Supply Chain, Disposition, or Quality on the Floor. The role will be responsible for managing quality operations functions, including lot disposition, Quality Management System (QMS) record approval, quality on the floor activities, supporting client and regulatory audits, including responses and continuous improvements. This position interacts regularly with clients. The Memphis site supports a CDMO cell therapy manufacturing site.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Oversee the review and approval of production batch records, specifications, and lab data.

· Ensure all release data, investigations and change controls related to Cell Therapy manufacturing and facility operation are documented and complete.

· Lead, develop, and mentor a team of Quality Operations employees.

· Responsible for ensuring the release of Raw Materials based on Client specifications and regulatory standards.

· Interfaces with and provides QA oversight of all raw material receipt, storage, and issuance.

· Develop training materials to ensure that Quality Operations employees meet the requirements of the company and clients.

· Work collaboratively with the Biomanufacturing, Quality Systems, Quality Control, Project Management, Facilities, and Supply Chain units to meet company and client goals.

· Provide oversight for On the Floor Quality activities for batch release of raw materials and GMP manufacturing.

· Perform failure analysis, risk assessment and mitigation as related to Good Manufacturing Practices (GMP) facility operations.

· Support client and regulatory audits, as well as internal audits.

· Provide support and approval of quality systems records.

· Review GMP investigations of product specific deviations, OOS, OOT and corrective actions to ensure compliance.

· Manager Quality Operations supporting Quality on the Floor will be required to gown into clean room environment.

Job Qualifications

Bachelor’s Degree in biology, biochemistry, chemistry or other science related field preferred or equivalent experience in leu of education requirements.

· 5 - 8 years of experience within a GMP Environment

· 5+ years of experience within professional level Quality Assurance, Quality Operations, or Compliance preferred

· 3+ years in a supervisory or leadership role is preferredStrong knowledge of FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations

· Solid understanding of Deviation, CAPA, Change Control, Auditing practices/strategies

· Excellent interpersonal, verbal, and written communication skills are meaningful in this collaborative work environment.

· Proactive, detail-oriented, and comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.

· Strong analytical, problem-solving, and project management skills.

· Experience reviewing and releasing Final Product preferred

· Experience in Cell Therapy and CDMO preferred

Compensation Data

The pay range for this position is $98,000 - $118,000. Please note that salaries vary within the range based on factors but not limited to experience, skills, education 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.

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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