GMP Quality Assurance Manager

Req ID #:  175432
Location: 

Shrewsbury, MA, US, 01545

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. 

Basic Summary

 

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.
  • Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
  • Assist in the development and recommendation of departmental budget and authorize expenditures.
  • Develop and oversee the implementation of departmental training programs, including orientation.
  • Support the policy of equal employment opportunity through affirmative action in personnel actions.
  • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
  • Performs all other related duties as assigned

Minimum Qualifications

Education:  Bachelor’s degree (B.A./B.S.) or equivalent 
Experience: Minimum of five (5) years’ experience in QA/Regulatory Affairs in the pharmaceutical and/or biotechnology-based industry, working in a GMP qualify role preferred. Minimum of 2 years of supervisory experience required.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certifications: None
Other: Experience in supervision quality assurance, quality control, and/or regulatory affairs.
Experience working in a GMP environment, 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.

 

PHYSICAL DEMANDS:

  • Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. 
  • Must regularly communicate with employees/customers; must be able to exchange accurate information.
  • Must occasionally move about inside the office to access file cabinets, office machinery, etc. 

 

WORK ENVIRONMENT:

  • General office working conditions; the noise level is usually quiet.

 

COMMENTS:

  • Requires occasional domestic travel.

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. 


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: Worcester

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