Manager Pre-Production Quality

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.