Quality Assurance - Administrative
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.
Job Summary
The Senior Specialist, Quality Systems and Compliance is responsible to provide oversight to the Quality Management System for compliance to applicable CGMP regulations. This includes but is not limited to the following:
Key Responsibilities and Duties:
· 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 and meet to meet company client goals.
· 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. Follow-up with the task owners for the timely completion of the audit task. Prepare the final CAPA response for review and approval by Director, Quality Assurance.
· 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, quality manual, policy gap assessments).
· Responsible to manage Deviation records, Change Control, Corrective Action and Preventive Action, Effectiveness Verification, Audit, 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.
· Responsible for performing regulatory gap assessment when a new regulation is released, or existing regulation is updated.
· Manages the internal audit programs.
· Maintains management review system and ensure its implementation. Monitor quality metrics and
provide periodic update to the senior management.
· 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.
· 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.
Job Qualifications
· BS required; MS preferred in scientific/technical discipline.
· Minimum of 7 years of experience in managing Quality Systems in 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.
The pay range for this position is $110K - $125K. Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.
About Charles River’s CDMO Services
With over 20 years of experience and industry-leading expertise, Charles River’s cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities—including plasmid DNA, viral vector, and cell therapy manufacturing—enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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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