Job Summary

The Product Quality Lead will be the primary point of contact for the customer on all matters related to Quality Assurance and Quality Control. This position requires a deep CDMO/GMP quality knowledge, highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. Responsible for contributing to key functional, tactical, and operational aspects of the Memphis CDMO site. This includes approval & oversight of QC activities associated with exceptions, CAPA, deviations, Analytical instrument validation, change control requests, and other documentation related to QA operations. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with directives and procedures, customer requirements, and regulatory standards. 

•    Develop and shape a best in class Quality experience for clients by executing timely and effective responses and corrective actions for quality topics
•    Ensure strategic alignment with deliverables by leading execution efforts across key internal and external stakeholders
•    Coordinate inputs from clients and Quality Operations functional team from work statement approval through to project completion
•    Ensure timely awareness of quality agreements to key functional representatives and Quality Operations function
•    Provide specific technical knowledge for the Quality Unit organization (participating on investigations, studies, and trending evaluation as well as innovation and continuous improvements projects) 
•    Delegate tasks within the Quality Operations function and drive progress to completion during execution to the required standard (internal and customer’s) and ensure on-time completion of Quality deliverables
•    Attend and participate in client meetings, Tech Transfers, and other related meetings in support of client projects
•    Collaborate to ensure that tasks are prioritized, completed on time, and communicated in an effective and timely manner
•    Perform, review, approve (as applicable), and follow up tech transfers and methods validation documentations related to the different customer´s projects
•    Perform the monitoring of the process from the quality perspective
•    Supports Lot Disposition for the batch release (Deviation, Change Control)
•    Review and approve (as applicable) Stability Protocols and Reports. 
•    Develop and implement reporting to track key metrics quickly identifying trends to drive proactive resolution in compliance with internal and external guidelines, standards, and regulations
•    Build trust and influence within different departments of the operation by being a top Quality advisor to Operators and Clients.
•    Participate in client and regulatory audits
•    Actively mentor other quality professionals at CRL to deepen business and quality acumen
•    Effectively model, demonstrate and live an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee. 
•    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.

Job Qualifications

• High school diploma or equivalent required.  Bachelor degree or equivalent years of experience preferred
•   Minimum 10 years of related industry experience and 5+ years of leadership experience

•    Understanding of US and EU cGMP guidelines and requirements
•    Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc.) to functional area leadership
•    Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
•    Ability to understand operational documents for GMP compliance, accuracy, and completeness
•    Ability to work by influencing a matrix management system and to gain the cooperation of others
•    Strong client-facing interpersonal skills coupled with a concern for impact
•    Strong time management and organizational skills
•    Excellent written and oral communication skills both internal and external
•    Able to manage multiple priorities and demonstrate self-control
•    Ability to resolve conflict within project teams
•    Exhibit good leadership skills
•    Strong attention to detail
•    Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community
•    Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.
•    Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.

•    3 or more years’ experience being a super user of Trackwise Digital, SmartSolve, Maximo, and other Quality related systems
•    2 plus years in developing and maintaining budgets at a department level
•    Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.
•    ISO Lead Auditor training, desirable.
•    Certified Quality Engineer (ASQ), desirable
•    3 plus years leading projects that involve multiple departments and outside organizations
•    PMP certified is a plus

The pay range for this position is $160,000 – $180,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.