Job Summary

This role serves as a senior Quality Assurance Subject Matter Expert (SME) supporting the GMP cell therapy manufacturing operations. This roles plays a strategic part in ensuring compliance across the quality system, providing technical leadership for complex investigations, regulatory readiness, and cross-functional quality decisions. This position is hands-on expert who can partner across departments while maintaining a strong compliance posture in a fast-paced evolving environment. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•    Performs full investigations of major events with potential product quality impact for complex products to identify the root cause, impact assessment, and CAPA to assess quality requirements for compliance with regulatory requirements
•    Provides Quality Assurance (QA) assessment and approval for Change Controls, supports Quality Management activities with strategic initiatives and metrics, assembles Change Control Assessments, supports Deviation Risk Assessments and reviews and approves CAPAs
•    Lead or contribute significantly to top regulatory inspections preparation, hosting and response efforts. Offer guidance on Good Manufacturing Practices (GMP) compliance strategies related to cell therapy processes, raw materials, and supply chain controls. 
•    Collaborate cross-functionally with Manufacturing, MSAT, Supply Chain, Quality Control and  Regulatory to drive right-first-time execution and continuous improvement. 
•    Support QA oversight of aseptic operations and cleanroom behavior, serving as a QA lead during critical operations in compliance with cGMP and SOP regulations, as needed. 
•    Actively lead, coach and mentor other quality professionals and other individuals from all parts of CRL with varying levels of experience to deepen business and quality acumen
•    Perform preventative tasks and provide documentation to avoid deviations 
•    Perform periodic assessments of Quality related data and documentation to maintain a state of audit readiness
•    Influences as a resource and departmental SME for Quality related questions or topics including Regulatory, Corporate, and Site-specific requirements
•    Delegate tasks within the Quality Operations function and drive progress to completion during execution to the required standard and ensure on-time completion of Quality deliverables
•    Ensure strategic alignment with deliverables by leading execution efforts across key internal stakeholders
•    Strong attention to detail
•    Triage real-time quality impact of events in conjunction with employees in support of deviation management
•    Conduct internal audits of facility, equipment, manufacturing areas, and warehouse and provide written reports summarizing findings 
•    Recommend improvements in QA through procedures or processes as they relate to inspection readiness and compliance
•    Perform trending and analysis of deviations and works with responsible area owners to identify opportunities for improvement
•    Build trust and influence within different departments of the operation by being a top Quality advisor to Operators
 

Job Qualifications

• Bachelors degree in a life science or related field preferred
• Minimum of 8 years GMP related experience in biopharmaceutical and/or pharmaceutical or related industry or a combination of  6 years of education and related work experience required
• 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
• Ability to multi-task effectively
• Excellent written and verbal communication skills
• Ability to prioritize daily activities in order to meet internal needs on time of established time lines in a fast-paced environment
• Proficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power Point) and Quality Management Systems such as Trackwise, SmartSolve, and Maximo

The pay range for this position is $95,000 – $136,000.  Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.