Senior Manager, Quality Engineering - Cell and Gene

Job Description

GENERAL POSITION SUMMARY:

The Sr. Quality Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Sr. Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

KEY RESPONSIBILITIES:

• A member of the Vertex Cell and Genetic Therapies (VCGT) Quality Engineering group primarily responsible with providing quality oversight and support to operations at the Providence GMP manufacturing site in the following key areas/activities; engineering, validation/qualification and facilities and utilities support.

Compliance Oversight of Internal Operations – QA Engineering

• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
• Review and approval of qualification activities (instruments, equipment, facilities, utilities) and periodic assessments.
• Review and approval of trending programs (equipment, facility, utilities, etc.)
• Support EM and Routine testing of facilities and utilities and control programs (EMS, pest control)
• Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned.

• Responsible for training staff on ILTs and OJTs as applicable

Compliance Oversight of Quality Systems

• Provide QA support of Equipment and Facility change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Chair/lead the change control review meeting and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
• Responsible for monitoring and tracking performance metrics, trends; including site metrics for investigation/CAPA, Equipment and Facility Change Controls, etc.
• Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement.
• Lead compliance walkthroughs of the site and help drive the closure of any observations.
• Responsible for identifying risks and communicating gaps for GMP process/systems.

Quality Process and Ownership of Equipment and Facility Change Controls and Equipment and Utility Qualifications

• Serves as document owner for cross-GxP process and responsible for identifying risks and communicating any gaps for quality processes optimization for Equipment and Facility change controls, Equipment and Utility qualifications, quality systems etc.
• Lead/participate in work process optimization, continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
• Serves as process training owner

Cleaning Validation Support

• Responsible for providing QA oversight of internal cleaning validation activities and evaluation of process being in a state of control.
• Responsible for review/approval of validation protocols and reports

Audit / Inspection Support

• Serves as Subject Matter Expert (SME) on Equipment and Facility Change Control and Equipment and Utility Qualification.
• Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations.

Deployment of QMS and Establishment of Compliance Expectations

• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
• Reviewer and/or approver of SOPs and Work Instructions as assigned.
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.
• Contribute to the design, development and implementation of GMP topic specific training program (e.g. Lunch and Learns)

Individual Development and Training

• Responsible for timely completion of trainings (100% on-time), goal development, self-evaluation and IDP

REQUIRED EDUCATION AND EXPERIENCE:

• Demonstrated success independently leading cross-functional teams
• Experience providing QA support and oversight of GMP manufacturing operation
• Experience with cell therapy drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
  • cGMP’s and associated CMC regulatory considerations
• Experience with equipment, facilities and utility system qualifications activities in a cGMP setting, including quality management of change controls
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• M.S (or equivalent degree) and 4-5 years of relevant work experience, or
• B.S in scientific or allied health field (or equivalent degree) and 9+years of relevant work experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

On-Site and work 5 days per week with ad hoc flexibility;

#LI-AR1 #LI-Onsite

Company Information