Job Summary

This strategic global role will identify and drive Quality Control Testing and overall Quality Optimization strategic initiatives for they Charles River Laboratories’ CDMO business unit.  Specifically, the individual filling this role will be responsible to build customer value in two ways:  ensuring all CDMO sites have appropriate QC testing abilities  locally that satisfies CRL, customer and GDP standard and through continuous improvement projects and best practice sharing drive harmonization throughout the Quality function at all CDMO sites. This role requires collaboration, consultation, and support to CRL CDMO teams and clients to ensure quality processes and customer value are delivered throughout the different locations and product/services offered in CRL’s CDMO business line. 

This role will involve analyzing data, building business cases, collaborating with cross-functional teams, and driving continuous improvement initiatives to ensure high-quality value for our customers.  A key aspect of this role is to ensure that the business meets regulatory quality standards across the global while driving synergies, time and cost savings in all the CDMO locations.  

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•    Develop and maintain a robust knowledge of CRL network capabilities by serving as a connector across CDMO sites to identify best practices, harmonize quality approaches and measurements, and drive network-wide improvements.
•    Stay up to date on Quality trends within the CDMO Industry and Pharma at large.
•    Influence business leaders to push projects that build capabilities in quality and create harmonization
•    Build business cases for project and change justification
•    Track project health of all QC Testing and Harmonization projects until ROI has been realized
•    Maintain a network of CRL Quality and Operational Associates to help identify and drive projects at different sites
•    Harmonize Quality process and language across all CRL CDMO sites
•    Serves as 1st level Subject Matter Expert for all new QC testing requirements and process improvements
•    Support Executive Director of CDMO Quality as champion of continuous improvement and operational excellence to align organization with industry best practices, and where appropriate, mentoring cross-functional teams to advance continuous improvement mindsets and projects.
•    Collaborates with Regulatory and Compliance teams when needed on Audit and Inspections
•    Develops and reports on CDMO wide Quality Metrics
•    Consults with Global and Site Quality Teams to identify training needs and content
•    Provide support to sites during regulatory and client inspections/audits
•    Participate in Regulatory Affairs and Compliance projects and programs.
•    Drive and ensure adherence to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
•    Perform all other related duties as assigned.

Job Qualifications

•    Bachelor’s degree (B.A./B.S.) or equivalent 
•    Three to five years’ experience working within Quality at a pharmaceutical and/or biotechnology company 
•    Detail-oriented, with the ability to manage complex problems, maintain a high level of confidentiality, require minimal direction and ability to work within a team environment
•    Ability to manage, prioritize, and multi-task various responsibilities
•    Ability to deliver information in a digestible format at various levels
•    Ability to travel to directly support sites as needs arise (approximately 30% of time)
•    Five plus years of experience using and improving common CDMO systems like ERPs, MES, LIMS, LES, DSS(Decision Support Systems), QMS and other tools
•    Have a proven history of driving continuous improvement projects and culture
•    Lean Six Sigma Black Belt or Master Black Belt certified from one of the following organizations: CSSC, IASSC, ASQ, or SSGI
•    At least five years’ experience interacting with FDA and EU Health Authority
•    MBA or Masters in Quality Systems and Improvement Management preferred
•    First hand Knowledge of SAP, Labware 7, MODA, Kneat, SmartSolve and Trackwise preferred

Compensation Data

The pay range for this position is $120,000-130,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.