Manager Post-Production Quality

Charles River • Full-time • Rockville, MD, US • $110,000 - $130,000 / year • 4w ago

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 of Post Production Quality reports to the Site Head of Quality. This role will be responsible for Quality oversight of process and materials after the manufacturing process is completed. This includes Sample Logistics, Dispostioning, as well as client communication through the QA and QC Program leads. 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 production clients.

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.
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.
Coordinating the collection of representative product samples from production lines, ensuring proper labeling and documentation to maintain traceability throughout the process.
Performing quality checks on samples before shipment to ensure they meet established standards and specifications.
Responsible for process and executing batch record reviews completeness, accuracy and adhearance to cGMP compliance for end product and intermediates
Supervise the Quality Program leads, who are responsible for client communications during the production process, to ensure customer service and program KPIs are met successfully.
Preparation of 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.
Maintain quality system controls for area of oversight to ensure no critical and major market complaints/Audit Findings.
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.
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
5+ years of experience within professional level Quality Assurance/Operations, Compliance, Supply Chain/Materials Management
2+ years in a supervisory or leadership role
Experience 5 - 8 years of experience within a GMP/ Good Distribution Practice (GDP) Environment preferred
Six Sigma Green or Black Belt Certification is preferred
Certified Quality Engineer (ASQ), desirable
ISO Auditor training, desirable.
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.

Compensation Data

The pay range for this position is $110,000 - $130,000 annually. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, 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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