Associate Director, Quality Systems - Cell and Gene Therapies (VCGT

Job Description Position Summary

The Quality Systems Associate Director supports strategicdesignofand ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization.

The roleis responsible forpartnering with cross-functional technical development and commercial teams to align andfacilitateharmonization of strategy, procedures and processes related to the Quality Management System and to drive Quality improvements.

This position reports directly to the Director of Quality.

-Process Lead for Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA) including:

• Responsible for leading and providing functional process oversight for APQR and QPQA

• Ensure all APQR and QPQA are executed on time andin accordance with procedures and regulatory requirements

• Monitor and support the quality riskmanagementprogram items associated with CGT.Identify and implement continuous improvement projects to improve processes and make them efficient and scalable

-Process Lead for VCGT Data Integrity (DI) program

• Define DI complianceoperationalstrategiesto bedeployedat the local site levelandmonitoredfor effectiveness, including governance

• Collaborate with Global Process owner toidentifyand implement DI continuous improvement projects to mature processes and make them efficient and scalable

• Responsible for local Quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management

• Leads the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans

• Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions

• Provide hands-onexpertisein theday-to-day management of data collection systems and control within theGxPQuality Management System using digital solutions

• Responsible for strategic, Risk Management monitoring support, and Data Integrity initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes

• Supports internal audit or external audit programs

• Works to enhance Quality Culture across VCGT organization

• Provides Project Management leadership for department projects/initiatives.

• Bachelor’s degree in a scientific discipline, operations research, operations management, business administration or a related field

• Requires 10+years of experience or the equivalent combination of education and experience

• Experience in product life cycle from discovery to commercial product development

• Broad and deepexpertisein global GMP regulations,guidances, and Quality Management Systems, as well as a strong understanding of industry standards and best practices across theGx Plifecycle

• Strong leadership skills with ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment

• Ability to assess impact across multiple procedures and systems

• Ability to lead and manage complex projects/teams within corporateobjectivesand project timelines

• Proficiencyutilizingproject management processes / tools to lead meetings,assist with project planning andfacilitatecompletion of tasks

• Excellent technical writing,presentation and communication skills

• Ability to effectively influence others within technical area of expertise

• Outstanding facilitation,communication, and coaching/influencing skills

• Proven ability to lead improvement projects and project teams

• Ability to navigate through ambiguity and rapid growth and adapt to change

• Proven ability toidentifyand analyze performance indicators.

• Extensive experience conducting investigations, performing root causeanalysisandidentifyingCAPA

Up to 15% travel

$148,000 - $222,000

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an…