Children's Healthcare of Atlanta

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Work Shift

Day

Work Day(s)

Friday, Monday, Thursday, Tuesday, Wednesday

Shift Start Time

8:30 AM

Shift End Time

4:30 AM

Worker Sub-Type

Regular

Children’s is one of the nation’s leading children’s hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We’re committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children’s.

Job Description

The Advanced Cell Therapy Quality Program Manager is responsible for the Advanced Cell Therapy Facility Quality Management Plan, GMP vendor qualification, deviation & CAPA management, document control, change control, quality review and approval of manufacturing and release testing, facility audits, and compliance with policies, standards, procedures, and global cGMP. The role will provide quality management, oversight, and assure that the quality of manufactured products is in compliance with all applicable regulations and guidelines.

This role will build analytics capabilities for quality management, and will help build out processes, tools, and capabilities to support manufacturing site operations. The Program Manager will serve as an active partner with a range of site teams, including manufacturing operations, supply chain, quality, and compliance to develop data driven insights and reporting, and improve manufacturing site performance through automation, simulation, and predictive modeling.

Experience

• 4+ years working in a FACT accredited facility
• 4+ years of direct experience in Quality Assurance and Quality Management
• 7+ years of experience working in a cell therapy manufacturing site role
• Knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements
• Experience with 5-WHY, and other Root Cause Analysis tools to structure and aid problem solving activities within a cross-functional team determining appropriate corrective/preventative actions as a result of investigation findings

Preferred Qualifications

• Master’s degree in a life sciences or engineering discipline
• Six Sigma Green Belt

Education

• Bachelor's degree in medical technology, life sciences or engineering discipline

Certification Summary

• ASQ certification or equivalent, obtained up to one (1) year from date of hire

Knowledge, Skills, and Abilities

• Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills
• Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy
• Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams. Able to effectively work across functional groups and teams to ensure requirements are met
• Demonstrated background in core Quality Management System (QMS) concepts, QMS architecture, QMS improvement activities
• Demonstrated background of data-analytics for continuous improvement
• Action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking
• Confident in making decisions for minor issues and routinely recognizes quality issues and solves problems
• Strong authorship and ability to critically review policies, standard operating procedures, forms, and batch process records, interpret results from validations and/or release testing and generate technical conclusions consistent with Quality risk management principles
• Recognized as the Subject Matter Expert within cellular therapy processes and regulatory requirements
• Knowledge of applicable business systems including EPIC, LIMS, and Master Control
• Excellent project management skills with demonstrated ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
• Strong knowledge of US cGMP regulations/guidance and some experience with regulatory agency inspections
• Expert in FACT standards and accreditation
• Strong knowledge of analytical methodologies such as flow cytometry, cell-based assays, qPCR, ELISA, BACT, endotoxin and applying/interpretation of GMP requirements
• Skilled at communicating analytics output to a wide range of audiences
• Strong ability to build effective relationships with stakeholders, business partners and external parties
• Excellent written and verbal communication skills

Job Responsibilities

• Oversee both Quality Assurance and Quality Control functions across all GMP processes, for internal and external operations.
• Oversight and operations of the vendor qualification program and product critical quality attributes.
• Establish and maintain systems to review, modify, and approve all policies and Standard Operating Procedures intended to monitor compliance with these Standards or the performance of the Processing Facility.
• Provide leadership to realize a culture of quality across all assigned operations, promoting the escalation of quality issues for appropriate corrective action.
• Ensure continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of facility operations, processes, and products.
• Develop and implement a phase-appropriate and fit-for-purpose Quality Management System, procedures, and processes, following a risk-based approach, consistent with current regulatory and industry standards.
• Hire, lead and develop a team of quality professionals capable of overseeing quality review operations while establishing and maintaining high performance standards.
• Develops and maintains internal and external audit programs to satisfy contractual and regulatory requirements for GMP.
• Ensure Quality oversight for the optimization of new or existing products, processes, techniques, procedures, or facilities/equipment to ensure compliance with quality criteria.
• Interact with US regulatory agencies in regard to GMP matters. Coordinate the Quality review of documents for regulatory submissions. Oversee inspection readiness, preparations, and corrective action responses.
• Participate in a minimum of 10 hours annually of continuing education activities.

Children’s Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law.

Primary Location Address

2220 North Druid Hills Road

Job Family

Research