Associate Director of GMP Quality Assurance

Req ID #:  214753

Shrewsbury, MA, US, 01545

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.   

Basic Summary

Responsible for managing the Quality Assurance program at a Charles River operation and serves as a member of the Regulatory Affairs and Compliance management team.  Provides direction in implementing the Charles River Compliance Program and coordinates with peers to promote consistency in quality assurance operations, regulatory interpretation, and processes.  Works with the site management team to assure regulatory compliance and consistency with Charles River policies and procedures.


  • Communicate all identified compliance and quality risks to his/her supervisor.
  • Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled
  • Identify the need for, and assist in the development of, Corporate Quality and Compliance Policies. 
  • Manage Quality Assurance operational groups to assure inspections and audits are accurate, thorough, timely, and provide the correct interpretation of regulatory requirements and corporate policies.   
  • Assure staff receives appropriate regulatory and management training, and mentoring to enable the execution of regulatory and management responsibilities.
  • Assume a lead role in the development and presentation of regulatory training for Quality Assurance and operations staff.
  • Monitor the effectiveness of subordinate managers in managing compliance systems and assuring the 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; and
    • (5) Regulatory Affairs and Compliance projects and programs.  
    • Identify and resolve any scheduling conflicts and program priorities to assure timelines are fulfilled.
  • Monitor the effectiveness of subordinate Quality Assurance managers in reviewing Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.  
  • Identify and resolve inconsistencies between Quality Assurance audit teams should they occur. 
  • Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
  • Serves as a liaison with operations managers to identify regulatory deficiencies, explain audit findings, resolve conflicts, and consult on corrective and preventative actions. 
  • Assemble, evaluate, and report group metrics measuring compliance and quality key performance indicators. 
  • Represent the corporation during regulatory and client inspections/audits
  • Prepare site/operation personnel for client and regulatory audits and prepare appropriate summaries and reports of such audits.
  • Lead the preparation of regulatory and client audit responses and corrective action commitments.
  • Monitor site/operation corrective actions commitments and communicate “at risk” commitments to management with recommendations for their timely resolution.


  • Identify practices, methods, and processes for improvement and assist other operations on related compliance issues. 
  • 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.
  • Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings, intranet communications, and relevant strategic planning sessions.
  • Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
  • Direct 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,
    • delivering annual performance and salary reviews.
  • Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
  • Integrate activities with those of other major organizational units (e.g. segments, departments, functions).
  • Develop and recommend 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].
  • Communicate all identified compliance and quality risks to his/her supervisor.
  • Performs all other related duties as assigned.


  • Bachelor’s degree (B.A. /B.S.) or equivalent.  Advanced degree in biological sciences, pharmaceutical sciences, or computer sciences preferred.
  • Seven to Ten years related 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.
  • Strong experience and direct responsibility for management of Quality Assurance programs. 
  • Experience with direct management of QA audits and inspections as well as interfacing with regulatory agencies and preparing/reviewing responses to any inspectional findings.
  • Strong knowledge of pertinent national and international regulations pertaining to the pharmaceutical and biotechnology industries. 
  • Demonstrates strong leadership ability, communication, and facilitation skills. 
  • 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. 
  • Requires regular domestic and international 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. 

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 This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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Nearest Major Market: Worcester

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