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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.
The Sr. Manager/ Manger, Quality Assurance (Quality Systems and Compliance) is responsible to lead, mentor and coach team of specialists and associates and provide oversight to the Quality Management System for compliance to applicable CGMP regulations.
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.
• Manages and schedules Quality Assurance personnel for support of CGMP regulated operations.
• Participates in strategic, proactive planning of organizational activities, as required, with the goal of providing compliance expertise to Regulatory Commitments and Registrations.
• Co-hosts/ Participates in Regulatory Inspections and Potential Client Audits. Compiles a response for client/ regulatory agencies' audit findings. Assigns CAPA to task owners.
• Work with clients, external suppliers, and contract labs to ensure compliance and quality, including management of audits and quality agreements
• Prepares, reviews, approves/rejects CGMP documents (i.e., system level SOPs, internal audit plan, Vendor Audit plan, Approved Supplier List, quality manual, master validation plan, policy gap assessments, batch production records).
• Responsible to manage Deviation records, Change Control, Corrective Action and Preventive Action, Effectiveness Verification, Audit, Training, complaint management, recalls and Laboratory Investigations (including Out of Specification) if they are prepared, assessed, and investigated per the approved procedures and regulatory expectations. Qualify owners of DEV, CAPA, CC and EV with appropriate trainings.
• Identifies the required initial and continuing training for quality systems and compliance and ensures all employees are trained on appropriate curricula.
• Reviews process development and technology transfer data for compliance to internally approved standards and applicable regulatory requirements so that the manufacturing process, control strategy, process qualification (as required) and ongoing continual improvement is achieved.
• Responsible for performing regulatory gap assessment when a new regulation is released, or existing regulation is updated.
• Oversees the revision, issuance and tracking of controlled documents used to support regulated GMP activities.
• Manages the Quality Risk Management process during the qualification and identification of quality events.
• Ensures the data integrity, computer system validation/qualification and equipment and utility programs are implemented, and systems are in a state of control.
• Drives continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Actively participates in all recruiting efforts to secure, onboard, and develop new staff members. Assigns work, provides feedback and coaching, and takes necessary actions.
• Perform Quality Control data and audit trail review.
• Additional duties as assigned.
• BS required; MS preferred in scientific/technical discipline.
• 5-8 years of experience in a Quality leadership role within the biological and/or pharmaceutical industry.
• Experience in managing Quality Systems 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.
• Certification from American Society for Quality 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
Job Segment: Pharmaceutical, Quality Assurance, Biology, Biotech, Laboratory, Science, Technology