Senior Manager, Quality Operations

Senior Manager, Quality Operations Req ID #:  210952 Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20850 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

  Job Summary  

The Sr. Manager/ Manager, Quality Operations is responsible to lead, mentor and coach team of specialists and provide oversight to the overall assurance of quality for CGMP products manufactured at Charles River Laboratories (CRL Rockville).  

Duties and Responsibilities

•    Provides the necessary leadership for creating a culture of Quality and Compliance that is well integrated and supportive of end-to-end supply.

•    Works with project teams and individual departmental staff to provide guidance and strong quality leadership.

•    Manages and schedule Quality Assurance personnel for support of CGMP operations.

•    Ensures only trained and experienced employees are involved in authoring and reviewing a controlled document.

•    Ensures current Good Manufacturing Practices (CGMPs) compliance for manufacturing of biological product, and compliance to 21 CFR Parts 210, 211 and 600 as applicable.

•    Monitors projects and help to resolve issues or escalate appropriately to ensure on time delivery of all client projects with management of effective risk mitigation plans and stakeholder communication.

•    Collaborates with full range of personnel in manufacturing and technical work teams that support Fill/Finish to identify root cause of a problem and determine appropriate corrective action and preventive action for investigations.

•    Manages the review (audit) of batch production records, EM test reports, cleaning records, material release documentation and quality control test reports, prepare BPR audit reports and follow-up with task owners for the completion of the identified deficiencies. 

•    Ensures that QA batch record review and lot release deliverables are client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements.

•    Alerts management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.

•    Manages the walkthrough program in GMP Manufacturing, quality control testing, storage and material receiving area for compliance to approved procedure.

•    Oversees the revision, issuance and tracking of controlled documents used to support the bulk and sterile fill biologic products.

•    Manages Quality Risk Management process during the qualification and identification of quality events.

•    Drives continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.

•    Perform Quality Control data and audit trail review.

•    Additional duties as assigned.

  Job Qualifications  

Qualifications:

•    BS required; MS preferred in scientific/technical discipline. 

•    Min of 8 years of experience in in a GMP environment

•    Min of 5 years of experience in the Quality leadership role within the biological and/or pharmaceutical industry. 

•    Experience in reviewing quality control test reports and batch production records clinical and commercial pharmaceutical/ biopharmaceutical manufacturing. 

•    Excellent working knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines. 

•    Experience in TrackWise, Pilgrim is preferable.

•    Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy. 

•    Exceptional oral and written communication skills to all organization levels and clients. 

•    Strong organizational skills; able to prioritize and manage through complex processes/projects. 

•    Ability to define problems, collect data, and draw valid conclusions. 

•    Extensive experience with writing and managing investigations and risk assessments. 

•    Previous experience as an auditor for internal and vendor audits

•    Ability to be hands-on and detail oriented. 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

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 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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: Washington DC

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