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 Manager Pre-Production Quality reports to the Site Head of Quality. This role will be responsible for Quality oversight of warehouse operations for incoming materials and quality oversight for material selection for products manufactured at the the Rockville facility. The responsibilities of this role also include oversight of onboarding new programs and establishment of master batch records and other aspects as part of new product introduction for successful execution of manufacture of batches. This role also supports client and regulatory audits and inspections and will be expected to oversee and execute implementation of continuous improvement initiatives. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cellular therapy production.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Oversees a wide variety of activities to ensure compliance with applicable regulatory requirements as it pertains to incoming material receipt and release and distribution to Operations for use.
Oversee new production introduction activities to establish master batch records, sampling plans and other requirements to facilitate high quality execution in first runs of programs.
Establishes and maintains procedures and processes to ensure compliance with the US and global current Good Distribution Practice (GDP) and current Good Manufacturing Practice (GMP).
Develop and track Key Performance Indicators (KPI) for responsible areas.
Participates in developing Standard Operating Procedures (SOPs) and other @types of documentation to ensure quality objectives are met.
Conducts gap analyses and risk assessments of processes & procedures against relevant GMP guidelines as well as company standards.
Participate in, or where relevant lead, local and corporate projects and process improvement initiatives, as required.
Take appropriate steps to reduce waste and losses in Quality processes and improve efficiency in ways of working.
Provides input for Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
Ensure completion and adherence to training of subordinates in area of oversight as per the job requirement.
Provide leadership to and ensure necessary Quality oversight to areas within span of control.
Effectively model, demonstrate and live the Charles River core values of Care, Lead, Own, and Collaborate
Lead, coach and mentor individuals from all parts of the organization with varying levels of experience. Be a valued resource for the site in all matters related quality and compliance.
Perform all other related duties as assigned.
Job Qualifications
Bachelor's Degree in life sciences or related field preferred
Experience supporting/hosting FDA and State Pharmacy Board inspections preferred
Resilient with the ability to deliver in a challenging environment while maintaining high degree of accuracy and attention to detail.
Ability to engage stakeholders and manage multiple projects to achieve objectives
Organized with a systematic approach to prioritization
Embodies the Charles River core values of Care, Lead, Own, and Collaborate.
Demonstrated management and collaboration skills
Outstanding verbal and written communication skills
5+ years of experience within professional level Quality Assurance/Operations, Compliance, Supply Chain/Materials Management preferred
2+ years in a supervisory or leadership role is preferred
Experience 5 - 8 years of experience within a GMP/ Good Distribution Practice (GDP) Environment preferred
Six Sigma Green or Black Belt Certification is preferred
ISO Auditor training, desirable.
Certified Quality Engineer (ASQ), desirable
Experience with SAP and other electronic quality systems desired
PHYSICAL DEMANDS:
Must be able to sit for long periods of time.
Must be able to lift, push, pull to 10 lbs. routinely; 20 to 30 lbs. occasionally.
Must be able to work standing, bending, and reaching overhead occasionally.
Compensation Data
The pay range for this position is $102,353 to $129,600. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
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 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 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.
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.
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