Senior Manager/Associate Director, Quality Systems and Enginee at Cellular Biomedicine Group Inc – Rockville, Maryland

AbelZeta is a clinical stage biopharmaceutical company focused leveraging our R&D capabilities to discover and develop T cell-based therapeutic products to treat cancer and inflammatory & immunological diseases. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US. We are seeking an Senior Manager/Associate Director, Quality Systems and Engineering, to join our team.

This position is responsible for supporting the site Technical Operations processes related to cGMP such as Commissioning, Qualification and Validation (CQV), Computer System Configuration Management and Computer System Validation (CSV). This position ensures compliance with AbelZeta’s procedures and all applicable regulatory guidelines. Assisting with the commissioning and qualification of AbelZeta’s manufacturing site, providing support to the site validation group tasked with implementation of new equipment and manufacturing suites. Maintaining the Validation Master Plan.

Responsibilities and Duties:

• Manages/Directs the Quality Engineering (QE) function to ensure enterprise-wide compliance with GxP requirements; leads the harmonization and optimization of quality systems
• Oversees the implementation, administration, and strategic planning for GxP Quality Systems, including the eQMS, Asset Management systems, and Environmental Monitoring platforms.
• Establishes and maintains policies and procedures for GxP systems compliant with 21 CFR 210/211, ICH, PIC/S, and ISO standards.
• Partners with IT to ensure GxP computer system compliance; implements and champions a robust Data Integrity Program.
• Evaluates current Validation Master Plan status (including CQV, CSV, and EMPQ) to identify gaps, propose mitigations, and lead remediation efforts.
• Manages/Directs the qualification and validation lifecycle (IQ/OQ/PQ) for facilities, software, and equipment, including the creation of master equipment files and risk assessment processes
• Provides quality oversight for equipment lifecycle management including commissioning, qualification, calibration, preventive maintenance, and engineering.
• Leads and supports the Facility Shutdown program, planned maintenance activities, and engineering initiatives affecting GMP systems.
• Manage and oversee CAPAs and Change Controls related to facilities, utilities, equipment, and computer systems.
• Manages/Directs administrative roles for GxP systems and maintains ownership of user lists for all QE-administered systems.
• Other duties as assigned

Qualifications and Requirements:

• Bachelor’s degree with 7 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product).
• Strong experience supporting Commissioning, Qualification, and Validation (CQV) of equipment, facilities, utilities, and manufacturing systems in a GMP manufacturing environment.
• Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).
• Experience managing equipment lifecycle programs, including qualification, calibration programs, preventive maintenance oversight, and asset management systems.
• Quality Engineering Certification (CQE), ASQ, Black Belt/Green Belt certifications, preferred. Proficiency in Computer System Validation, Automation, equipment, and utility IQ/OQ/PQ/PV in a GMP environment (Drug Substance or Drug Product).
• Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
• Strong working knowledge of GMP, GAMP5, SOP development, and quality systems governance.
• Experience with internal and external audit principles.
• Strong knowledge of change control practices/strategies.
• Proficient in MS Word, Excel, PowerPoint, and other applications.
• Ability to communicate and work independently with scientific/technical personnel.
• Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude.
• Ability to work effectively in a dynamic, fast paced environment with shifting priorities
• Ability to work collaboratively with teams and collaborators

Why You Should Join AbelZeta

• Join a high-growth and fast-paced organization.
• Defined career path and annual performance review and feedback process.
• Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!
• Competitive company 401k match.
• Paid holidays, sick leave, and annual leave.

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.