Senior Manager, Quality Validation and Engineering (On-site)

Job Description

GENERAL POSITION SUMMARY :

The Senior Manager, Quality Validation and Engineering is responsible for supporting routine operations and projects associated with GMP facilities, utilities, equipment, and analytical instrument lifecycle in support of Vertex Cell and Genetics Therapies internal operations.

This position is responsible for providing oversight of the facilities and equipment maintenance and calibration programs, site validation activities, and support for small / large CAPEX projects.

KEY DUTIES AND RESPONSIBILITIES

• Responsible for providing quality oversight and support ensuring compliance standards and practices are maintained for the following :
• Validation activities associated with the implementation of new or the modification of existing facilities, utilities, equipment systems and analytical instruments.

Support all phases of implementation from design, facility construction or system manufacturing, commissioning, qualification, and decommissioning.

• Review and approve validation documents, including associated change controls, validation plans, protocols, summary reports, risk management tools, validation deviations, and other ancillary supporting documents.
• Support validation maintenance activities including periodic assessments and system requalification ensuring planned activities are executed on-time per the annual plan.
• GxP Facilities Operations activities in scope of the preventive maintenance and calibration program. Approve associated CMMS work order records and activities associated with routine operations and planned facility shutdowns.
• Provide oversight for the facility control programs, including the environmental monitoring, utilities monitoring, qualified system monitoring and alarm system (EMS), and pest control program, including the review and approval of associated trend reports.
• Serve as Quality Lead for multiple projects of varied size and complexity that may include large CAPEX projects for a new GMP manufacturing facility with associated support utilities, manufacturing, and laboratory systems to small OPEX project for the modification of an existing system.

Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues.

Provide compliance oversight and support of various quality system and associated records which may include change controls, deviation investigations, and associated CAPA and effectiveness checks.

Responsible for identifying risks and communicating gaps to GMP process / systems.

• Participate in the change control review meeting and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
• Responsible for biennial review and approval of department and cross-functional processes for continuous improvement.
• Lead compliance walkthroughs of the site and help drive the closure of any observations.
• Support on-site internal audits and regulatory inspections and associated activities. These may include participation in inspection readiness activities, supporting during sight audits and inspections, and serve as quality subject matter expert (SME) for facility control programs and the validation lifecycle.

Provide post inspection support to address questions and / or observations.

• Lead and drive accountability of a diversified team of full time and contract quality professionals responsible for supporting activities outlined above ensuring compliance and deliverables are meet department and business goals.
• 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.

REQUIRED EDUCATION AND EXPERIENCE :

• Demonstrated aptitude for facilitating group or project team endeavors and building team unity
• Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process
• Demonstrated ability to work independently to provide QA support for large, multifaceted projects
• Demonstrated success independently leading cross-functional teams
• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.
• Experience with qualification of manufacturing equipment, laboratory instrument, and facility and utility system in a cGMP setting.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Experience with system automation, and network-based applications such as Oracle and Veeva preferred.
• 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
• Advanced degree in scientific and / or engineering disciplines with minimally 3 years of relevant work experience, or B.

S in scientific or engineering field (or equivalent degree) and 7+years of relevant work experience

On-Site Roles

On-Site designated role, you will work five days per week on-site with ad hoc flexibility.