Manager, Regulatory Compliance
Req ID #: 43545
Frederick, MD, US, 21703
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.
Conducts quality system inspections to support all regulated work intended to support the company's business segments.
Responsible for managing the Quality Assurance program component at a Charles River operation. Assists Regulatory Affairs and Compliance management in implementing the Charles River Compliance Program. Works with the site management team to assure regulatory compliance and consistency with Charles River policies and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Communicate all identified compliance and quality risks to his/her supervisor.
Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled.
Manage direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
Assure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities.
Schedule resources to manage compliance systems and assure timely completion of: (1) audits of regulatory records and reports; (2) inspections of facilities and equipment; (3) investigations, (4) audits of methods, practices, and controls.
Review and endorse Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management.
Represent the corporation during regulatory and client inspections/audits.
Coordinate the preparation of regulatory and client audit responses and corrective action commitments.
Track corrective actions and apprise management of their status.
Assure vendors and suppliers identified/designated by Charles River are assessed for the compliance with applicable regulatory requirements.
Participate in Regulatory Affairs and Compliance projects and programs.
Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
Manage activities of assigned group(s) to ensure optimum performance of the group/function.
Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
Education: Bachelor's degree (B.A./B.S.) or equivalent
Experience: Minimum of five (5) years experience in the pharmaceutical and/or biotechnology based industry.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Other: Experience in supervision quality assurance, quality control, and/or regulatory affairs.
Experience with assisting or managing QA audits and inspections as well as interfacing with regulatory agencies, Good working knowledge of pertinent regulations and site SOPs., Demonstrates strong leadership ability, communication, and facilitation skills.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
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 14,000 employees within 80 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. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
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 ~85% of the drugs approved by the FDA in 2018.
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet. 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.
Nearest Major Market: Washington DC
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