Manager, Regulatory Compliance

Charles River Frederick , MD 21703

Posted 2 weeks ago

Manager, Regulatory Compliance

Req ID #: 43545

Location:

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.

Job Summary

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.

QUALIFICATIONS:

  • 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

Job Segment: Toxicology, Biotech, Pharmaceutical, Manager, Quality Assurance, Science, Management, Technology


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Regulatory Affairs Specialist III

Thermo Fisher Scientific Inc.

Posted 6 days ago

VIEW JOBS 4/16/2019 12:00:00 AM 2019-07-15T00:00 Job ID : 92707BR Location : US - Maryland - Frederick : Job Description When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. How will you make an impact? * The Global Regulatory Affairs department in Thermo Fisher Scientifics Life Science Solution group is seeking a Regulatory Affairs professional to join the exciting area of molecular diagnostic products. This position will be located at the Frederick, MD facility * This position will support both IVD and RUO products primarily with respect to manufacturing support and regulatory compliance matters. This support will assist the company in achieving its business goals while ensuring compliance with various government regulation. * In addition to site manufacturing support, this position will provide support to the Genetic Sciences and Clinical Sequencing divisions as needed by performing additional regulatory activities including regulatory assessment of product changes, Labeling/Advertising/Promotional materials review, submit 30 day notices for manufacturing changes, submission support such as gathering submission documents, assist in drafting submission narratives and reviewing submissions prior to filing. These filings include 510(k)s, PMA supplements, or traditional PMAs. What will you do? * Responsible for providing regulatory compliance support for both IVD and RUO products to the Frederick, MD facility * Perform regulatory assessment of new and on market product changes * Review labeling / marketing materials for products against internal policies and external guidance /regulations * Under the direction and assistance of SR RA manager, assist in preparation of U.S. 510(k), PMA supplement, and traditional PMA submissions. * Preparation/maintenance of Technical Files for European CE-IVD products. * Prepare and maintain state and federal medical device licensing, establishment registration and listings * Prepare product field action and MDR reports * Obtain regulatory permits, including compliance with import / export clearance requirements and regulations. * Participate in project teams (existing products and new product introductions) * Will have direct line reporting to Sr. Manager of Regulatory Affairs. * Document regulatory strategies for product submissions. * Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. * Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team's knowledge of working in a regulated environment. * Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures. * Participate in site audits and inspections, both physical and paper, to ensure compliance with various regulations. How will you get here? * A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. Experience: * Must have a minimum of 5 years Regulatory Affairs experience within the medical device or IVD industry. * Must be well versed in the aspects of design control, cGMP/Quality Systems, labeling requirements, and has a good understanding in risk management, design and process verification and validation. * Experience in the balance and application of regulatory requirements * Capacity to communicate regulations to technical functions within the company * Multi-site experience, in a mid to large size company preferred. * Location: role is based in Frederick, MD * This position has not been approved for Relocation Assistance. Required Qualifications: * High energy level; positive attitude; works well under stress; strong communicator * Hands-on, action-oriented, and able to implement effectively through his/her team * Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency * Able to work autonomously in a matrix-managed organization * Ability to provide solutions based on knowledge of regulation and industry experience * Comfortable with ambiguity and change This position does not have relocation allowance At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Thermo Fisher Scientific Inc. Frederick MD

Manager, Regulatory Compliance

Charles River