Associate Director – Facilities & Engineering Operational Quality Assurance

Associate Director – Facilities & Engineering Operational Quality Assurance

Requirements

• Strong leadership skills with the ability to thrive in a high throughput environment
• Project Management / Continuous Improvement
• Ability to lead and manage complex projects/teams within corporate objectives and project timelines
• Proficiency utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
• Ability to independently lead cross-functional teams and represent the Quality unit
• Ability to effectively influence others within technical area of expertise
• Ability to communicate effectively across all organizational levels
• Ability to evaluate quality matters and make decisions utilizing risk based approach
• Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
• Strong validation background with knowledge of ASTM E2500, CSV/GAMP, and other associated standards
• Demonstrated ability to work independently to provide QA support for large, multifaceted projects
• 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 successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Experience with equipment, facilities and utility system qualifications activities in a cGMP setting, including quality management of change controls
• Experience with system automation, and network-based applications such as Oracle and Veeva preferred
• BS in Engineering, or related technical or scientific discipline
• Prior supervisory experience
• Minimum of 8-10 years industry experience working in medical or implantable biomedical devices

Responsibilities

• Responsible for providing quality oversight and support ensuring compliance with standards and practices are maintained across all internal Vertex CGT manufacturing sites for the following: Facilities and Equipment Preventive Maintenance and Calibration Program
• Support annual plant shutdown and other planned area shutdown activities, including providing guidance on containment and other controls to minimize impact on cleanroom spaces, provide technical support and strategy for return to service cleaning, testing, and GMP release of the facility
• Support the generation of metrics for monitoring KPI and communicating those to senior management and cross-functional stakeholders
• Review/analyze the effectiveness of the program, identifying gaps and opportunities for improvement
• Support quality event investigations of out-of-tolerance calibration activities ensuring robust product impact evaluation, effective root cause analysis and corrective actions
• Support the approval and extensions of CMMS work order records and associated supporting documents for preventive maintenance, calibration, and system change management records
• Responsible for oversight to ensure tactical execution of program requirements are carried out in compliance with Vertex standards and procedures
• Responsible for supporting program and associated electronic system change management
• Partner with cross-functional partners to ensure periodic trend reports are completed and reviewed on time, any emerging trends are identified and investigated, and robust corrective actions are implemented
• Provide oversight for the facility control programs, including the qualified critical system monitoring and alarm system (Environmental Monitoring System, EMS), and pest control program, Responsible for ensuring the tactical execution of program requirements are carried out in compliance with Vertex standards and procedures
• Responsible for monitoring and tracking performance metrics and trends for supported programs; including the development and presentation of metrics to site leadership and management review forums. Maintain team dashboards for assigned programs
• Serve as standing member or provide ad hoc support to the Facilities and Equipment Process Owner Network (PON) initiative
• Provide QA support for the implementation of process improvements and establishing program KPI
• Participate in risk identification by performing gap analysis, determining robust corrective actions, and risk communication
• Serve as Quality Lead or provide support for 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 new system implementation or modification existing system
• Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues
• Provide compliance oversight and support of 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 assigned department and cross-functional processes for continuous improvement
• Lead compliance walkthroughs of the site and help drive the closure of any observations
• Lead/participate in process optimization workstreams, continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources
• Serves as quality subject matter expert (SME) for facility control programs in scope of responsibilities outlined in this job description along with the associated validation lifecycle elements
• Participate in inspection readiness activities and provide support during regulatory site inspections. These may include participation in inspection readiness activities, preparation of SME presenters, leading strategy storyboard creation, and serve as quality subject matter expert (SME) for facility control programs
• Provide post inspection/audit support to address questions and/or observations. Serve as QA contact on CAPA records to implement response commitment

Preferred Qualifications

• Experience with system automation, and network-based applications such as Oracle and Veeva preferred