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QA Manager - Vigene

Charles River Laboratories International Inc (CRL)

Rockville, MD, US, 2085

QA Manager - Vigene Req ID #:  151197 Location: 

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

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 We are seeking a QA Manager for our Vigene BioSciences site located in Rockville, MD.    

 

The following are responsibilities related to the QA Manager:

 

Vigene Biosciences has been a leader at the forefront of cell and gene therapy, Adeno-Associated virus or AAV vector production, adenovirus vector production, lentivirus vector production, retrovirus vector production, plasmid production, viral vector QC and analytical services, plasmid QC and analytical services, providing services and products to support this rapidly growing and increasingly important field

The Quality Assurance Manager is responsible for developing and overseeing the implementation of the quality systems required by the GMPs.

DUTIES AND RESPONSIBILITIES Manage Quality Assurance personnel  Manage aspects of the Quality System to include but not limited to Quality Events, Quality on the floor batch records Assist with continuous improvements efforts within the manufacturing Be a cGMP officer to ensure site is inspection ready Provide regular training for the QA/Quality Control (QC) team members and to company employees to ensure proper cGMP knowledge Ensure the quality system is followed and adhered to for cGMP projects during the manufacturing process  Perform internal and external audits of the Quality System Take part in tracking audit responses and implement corrective action plans to ensure compliance to regulatory requirements In collaboration with the Managers, conduct random quality assurance testing of services to clients to determine quality of service and developing corrective action plans if services are not meeting expected outcomes Conduct quarterly reviews of all serious occurrences and compile a quarterly report for the Directors including recommendations for quality improvement  Job Qualifications  

  Bachelor of Science in life sciences or related field 5-7 years of QA and/or QC experience in a cGMP/FDA regulated industry 2-3 years of Management experience Knowledge of General Manufacturing Practice (GMP) and International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use (ICH) regulations Previous experience in CDMO and/or gene therapy industry preferred  Ability to handle pressure and meet deadlines Ability to manage multiple projects Effective communication (verbal and written) and teamwork skills Microsoft Office Experience (Word, Excel, PowerPoint, etc.) Gene Therapy experienced desired

 

 

 

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. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.

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, 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

Job Segment: Biotech, Manager, Laboratory, Pharmaceutical, Science, Management, Research

Job posted: 2022-01-26

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