Job Description

A clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapy products 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 on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients. We are seeking a Manager / Sr. Manager, Quality Engineering to join our team.

This position responsible for supporting the site Technical Operations (TechOps) 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 our procedures and all applicable regulatory guidelines. Assisting with the commissioning and qualification of our 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:

• Implement/execute computer system validation and general CQV.
• Support facility qualification/commissioning and operations/maintenance
• Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.
• Provide support for change control technical assessment/evaluation process.
• Align on change control requirements to manage the requested change.
• Implement qualification procedures.
• Responsible for system compliance aspects across the site’s project portfolio.
• Manage master equipment file.
• Support the site’s quality system management with measurement and control strategies.
• Support regulatory inspections and audits.
• Manage the risk assessment process for qualification and validation.
• Support vendor qualification and compliance audits.
• Review technical/investigation reports as appropriate.
• Write, review, and approve proposed changes to systems and procedures, as appropriate.
• Write, review, and approve protocols and summary reports.
• Track, review, and report metric information for use in continuous improvement of areas of responsibility.
• Support the Head of QA on continuous improvement initiatives and projects within the site’s quality organization.

• Perform other duties and tasks 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).
• Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).
• Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.
• Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).
• Automation, equipment, and utility IQ/OQ/PQ/PV.
• Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
• Strong knowledge of GMP, GAMP, SOPs, and quality systems.
• 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 in a dynamic, fast paced environment with shifting priorities

Ability to work collaboratively with teams and collaborators.